Trial Outcomes & Findings for Safety and Immunogenicity of Pfs25M-EPA/AS01 and Pfs230D1M-EPA/AS01 Vaccines, Transmission Blocking Vaccines Against Plasmodium Falciparum, at Full and Fractional Dosing in Adults in Mali (NCT NCT02942277)
NCT ID: NCT02942277
Last Updated: 2024-12-10
Results Overview
Number of participants with local and systemic adverse events (AEs) graded by severity occurring within 7 days after each vaccine
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
301 participants
Primary outcome timeframe
Within 7 days after each vaccination
Results posted on
2024-12-10
Participant Flow
Community permission was obtained from village elders and other community members in Sotuba/Bamako, Bancoumana, and Doneguebougou after explanation and discussion of the study at a community meeting. A general announcement inviting household and family members to the participating clinic to learn about the study was made at the time of community permission, using local radio or any traditional channel of communication.
Participant milestones
| Measure |
Pilot/Safety Arm 1a: Dosing Interval 0, 28, 168 Days
Participants received 3 doses of 16 μg Pfs25M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168
Pfs25M-EPA: The PpPfs25M and EcEPA lots, both manufactured at Walter Reed Bioproduction facility (Silver Spring, Maryland) in cGMP compliance, were used to manufacture the conjugate. PpPfs25M is a Pichia- expressed recombinant Pfs25 with a molecular mass of 18,713 Daltons.
The Pfs25M- EPA was formulated as conjugated Pfs25M in 4 mM PBS to a 2X dilution of the high dose (188 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
Normal Saline: Sterile isotonic (0.9%) normal saline was commercially procured in the US and shipped to Mali at ambient temperature. Normal saline was administered in a 0.5 mL dose as an intramuscular injection. Normal saline was also used for diluting Pfs25M-EPA and Pfs230D1M-EPA prior to formulation with AS01B for the lower dose groups in Bamako, Mali.
|
Pilot/Safety Arm 1b: Dosing Interval 0, 28, 168 Days
Participants received 3 doses of 47 μg Pfs25M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168
Pfs25M-EPA: The PpPfs25M and EcEPA lots, both manufactured at Walter Reed Bioproduction facility (Silver Spring, Maryland) in cGMP compliance, were used to manufacture the conjugate. PpPfs25M is a Pichia- expressed recombinant Pfs25 with a molecular mass of 18,713 Daltons.
The Pfs25M- EPA was formulated as conjugated Pfs25M in 4 mM PBS to a 2X dilution of the high dose (188 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
|
Pilot/Safety Arm 2a: Dosing Interval 0, 28, 168 Days
Participants received 3 doses of 13 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168
Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
Normal Saline: Sterile isotonic (0.9%) normal saline was commercially procured in the US and shipped to Mali at ambient temperature. Normal saline was administered in a 0.5 mL dose as an intramuscular injection. Normal saline was used for diluting Pfs25M-EPA and Pfs230D1M-EPA prior to formulation with AS01B for the lower dose groups in Bamako, Mali.
|
Pilot/Safety Arm 2b: Dosing Interval 0, 28, 168 Days
Participants received 3 doses of 40 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168
Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
|
Safety/Efficacy Arm 2c: Dosing Interval 0, 28, 168, 476 Days
Participants received 3 doses of 40 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, 168, and a 4th dose on Day 476 (Year 2). Participants received antimalarial drug treatment with Coartem® approximately 1 week prior to first vaccination.
Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 (Micro)g/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
Coartem: Artemether/lumefantrine (Coartem(R)) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used to treat malaria. Subjects who may have had any contraindications to the use of these drugs were excluded at screening. Coartem was dosed with food and administered over 3 days for a total of 6 doses, as per package insert and standard adult dosing
|
Safety/Efficacy Arm 2d: Dosing Interval 0, 28, 168, 476 Days
Participants received 3 doses of 40 μg Pfs230D1M-EPA/AS01 on Days 0, 28, then 8 μg Pfs230D1M-EPA/AS01 (100 µL TBV + AS01; fractional dose) on Day 168, then 4th dose of 40 μg Pfs230D1M-EPA/AS01 on Day 476 (Year 2) via intramuscular injections into the deltoid muscle (IM). Participants received antimalarial drug treatment with Coartem® approximately 1 week prior to first vaccination.
Participants underwent antimalarial drug treatment with Coartem on D-7 (prior to vaccination #1); 4th vaccination on D476
Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
Coartem: Artemether/lumefantrine (Coartem(R)) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used to treat malaria. Subjects who may have had any contraindications to the use of these drugs were excluded at screening. Coartem was dosed with food and administered over 3 days for a total of 6 doses, as per package insert and standard adult dosing
|
Pilot/Safety Arm 3a: Dosing Interval 0, 28, 168 Days
Participants received 3 doses of 16 μg Pfs25M-EPA/AS01 and 13 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, 168
Pfs25M-EPA: The PpPfs25M and EcEPA lots, both manufactured at Walter Reed Bioproduction facility (WRB; Silver Spring, Maryland) in cGMP compliance, were used to manufacture the conjugate. PpPfs25M is a Pichia-expressed recombinant Pfs25 with a molecular mass of 18,713 Daltons. The Pfs25M-EPA was formulated as conjugated Pfs25M in 4 mM PBS to a 2X dilution of the high dose (188 μg/ml in 0.5 ml volume) in cGMP compliance at WRB facility in Apr 2016 and was provided as a single use vial.
Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
Normal Saline: Sterile isotonic (0.9%) normal saline will be commercially procured in the US and shipped to Mali at ambient temperature. Normal saline was administered in a 0.5 mL dose as an intramuscular injection. Normal saline was be used for diluting Pfs25M-EPA and Pfs230D1M-EPA prior to formulation with AS01B for the lower dose groups in Bamako, Mali.
|
Pilot/Safety Arm 3b: Dosing Interval 0, 28, 168 Days
Participants received 3 doses of 47 μg Pfs25M-EPA/AS01 and 40 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, 168
Pfs25M-EPA: The PpPfs25M and EcEPA lots, both manufactured at Walter Reed Bioproduction facility (Silver Spring, Maryland) in cGMP compliance, were used to manufacture the conjugate. PpPfs25M is a Pichia-expressed recombinant Pfs25 with a molecular mass of 18,713 Daltons. The Pfs25M-EPA was formulated as conjugated Pfs25M in 4 mM PBS to a 2X dilution of the high dose (188 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
|
Pilot/Safety Comparator Arm 4a: Dosing Interval 0, 28, 168 Days
Participants received 3 doses of ENGERIX-B via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, and 168
Engerix-B: ENGERIX-B (hepatitis B vaccine; recombinant): is a sterile suspension of noninfectious hepatitis B virus surface antigen (HBsAg) for intramuscular administration. It contains purified HBsAg obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. Each 1-mL adult dose contains 20 g of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide. FDA approved for persons 20 years of age and older for a series of 3 doses on a 0-, 1-, 6-month schedule.
Normal Saline: Sterile isotonic (0.9%) normal saline was commercially procured in the US and shipped to Mali at ambient temperature. Normal saline was administered in a 0.5 mL dose as an intramuscular injection. Normal saline was also used for diluting Pfs25M-EPA and Pfs230D1M-EPA prior to formulation with AS01B for the lower dose groups in Bamako, Mali.
|
Pilot/Safety Comparator Arm 4b: Dosing Interval 0, 28, 168 Days
Participants received 3 doses of ENGERIX-B via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, and 168
Engerix-B: ENGERIX-B (hepatitis B vaccine; recombinant): is a sterile suspension of noninfectious hepatitis B virus surface antigen (HBsAg) for intramuscular administration. It contains purified HBsAg obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. Each 1-mL adult dose contains 20 g of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide. FDA approved for persons 20 years of age and older for a series of 3 doses on a 0-, 1-, 6-month schedule.
Coartem: Artemether/lumefantrine (Coartem(R)) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used to treat malaria. Subjects who may have had any contraindications to the use of these drugs were excluded at screening. Coartem was dosed with food and administered over 3 days for a total of 6 doses, as per package insert and standard adult dosing
|
Safety Comparator & Efficacy Comparator Arm 4c: Dosing Interval 0, 28, 168, 476 Days
Participants received 3 doses of ENGERIX-B via on Days 0, 28, and 168, then 4th vaccination of Menactra® on Day 476 (Year 2) via intramuscular injections into the deltoid muscle (IM). Participants received antimalarial drug treatment with Coartem® approximately 1 week prior to first vaccination.
Engerix-B: ENGERIX-B (hepatitis B vaccine; recombinant): is a sterile suspension of noninfectious hepatitis B virus surface antigen (HBsAg) for intramuscular administration. It contains purified HBsAg obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. Each 1-mL adult dose contains 20 g of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide.
Menactra: Menactra is FDA approved for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 (but does not protect against serotype B) for use in individuals 9 months through 55 years of age
Coartem: Artemether/lumefantrine (Coartem®) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used to treat malaria. Subjects who may have had any contraindications to the use of these drugs were excluded at screening. Coartem was dosed with food and administered over 3 days for a total of 6 doses, as per package insert and standard adult dosing
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Year 1
STARTED
|
5
|
10
|
5
|
10
|
56
|
61
|
5
|
10
|
10
|
10
|
119
|
|
Year 1
COMPLETED
|
5
|
8
|
5
|
9
|
49
|
51
|
5
|
9
|
10
|
10
|
104
|
|
Year 1
NOT COMPLETED
|
0
|
2
|
0
|
1
|
7
|
10
|
0
|
1
|
0
|
0
|
15
|
|
Year 2
STARTED
|
5
|
8
|
5
|
9
|
49
|
51
|
5
|
9
|
10
|
10
|
104
|
|
Year 2
COMPLETED
|
5
|
7
|
4
|
8
|
36
|
40
|
4
|
8
|
10
|
9
|
79
|
|
Year 2
NOT COMPLETED
|
0
|
1
|
1
|
1
|
13
|
11
|
1
|
1
|
0
|
1
|
25
|
Reasons for withdrawal
| Measure |
Pilot/Safety Arm 1a: Dosing Interval 0, 28, 168 Days
Participants received 3 doses of 16 μg Pfs25M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168
Pfs25M-EPA: The PpPfs25M and EcEPA lots, both manufactured at Walter Reed Bioproduction facility (Silver Spring, Maryland) in cGMP compliance, were used to manufacture the conjugate. PpPfs25M is a Pichia- expressed recombinant Pfs25 with a molecular mass of 18,713 Daltons.
The Pfs25M- EPA was formulated as conjugated Pfs25M in 4 mM PBS to a 2X dilution of the high dose (188 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
Normal Saline: Sterile isotonic (0.9%) normal saline was commercially procured in the US and shipped to Mali at ambient temperature. Normal saline was administered in a 0.5 mL dose as an intramuscular injection. Normal saline was also used for diluting Pfs25M-EPA and Pfs230D1M-EPA prior to formulation with AS01B for the lower dose groups in Bamako, Mali.
|
Pilot/Safety Arm 1b: Dosing Interval 0, 28, 168 Days
Participants received 3 doses of 47 μg Pfs25M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168
Pfs25M-EPA: The PpPfs25M and EcEPA lots, both manufactured at Walter Reed Bioproduction facility (Silver Spring, Maryland) in cGMP compliance, were used to manufacture the conjugate. PpPfs25M is a Pichia- expressed recombinant Pfs25 with a molecular mass of 18,713 Daltons.
The Pfs25M- EPA was formulated as conjugated Pfs25M in 4 mM PBS to a 2X dilution of the high dose (188 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
|
Pilot/Safety Arm 2a: Dosing Interval 0, 28, 168 Days
Participants received 3 doses of 13 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168
Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
Normal Saline: Sterile isotonic (0.9%) normal saline was commercially procured in the US and shipped to Mali at ambient temperature. Normal saline was administered in a 0.5 mL dose as an intramuscular injection. Normal saline was used for diluting Pfs25M-EPA and Pfs230D1M-EPA prior to formulation with AS01B for the lower dose groups in Bamako, Mali.
|
Pilot/Safety Arm 2b: Dosing Interval 0, 28, 168 Days
Participants received 3 doses of 40 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168
Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
|
Safety/Efficacy Arm 2c: Dosing Interval 0, 28, 168, 476 Days
Participants received 3 doses of 40 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, 168, and a 4th dose on Day 476 (Year 2). Participants received antimalarial drug treatment with Coartem® approximately 1 week prior to first vaccination.
Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 (Micro)g/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
Coartem: Artemether/lumefantrine (Coartem(R)) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used to treat malaria. Subjects who may have had any contraindications to the use of these drugs were excluded at screening. Coartem was dosed with food and administered over 3 days for a total of 6 doses, as per package insert and standard adult dosing
|
Safety/Efficacy Arm 2d: Dosing Interval 0, 28, 168, 476 Days
Participants received 3 doses of 40 μg Pfs230D1M-EPA/AS01 on Days 0, 28, then 8 μg Pfs230D1M-EPA/AS01 (100 µL TBV + AS01; fractional dose) on Day 168, then 4th dose of 40 μg Pfs230D1M-EPA/AS01 on Day 476 (Year 2) via intramuscular injections into the deltoid muscle (IM). Participants received antimalarial drug treatment with Coartem® approximately 1 week prior to first vaccination.
Participants underwent antimalarial drug treatment with Coartem on D-7 (prior to vaccination #1); 4th vaccination on D476
Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
Coartem: Artemether/lumefantrine (Coartem(R)) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used to treat malaria. Subjects who may have had any contraindications to the use of these drugs were excluded at screening. Coartem was dosed with food and administered over 3 days for a total of 6 doses, as per package insert and standard adult dosing
|
Pilot/Safety Arm 3a: Dosing Interval 0, 28, 168 Days
Participants received 3 doses of 16 μg Pfs25M-EPA/AS01 and 13 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, 168
Pfs25M-EPA: The PpPfs25M and EcEPA lots, both manufactured at Walter Reed Bioproduction facility (WRB; Silver Spring, Maryland) in cGMP compliance, were used to manufacture the conjugate. PpPfs25M is a Pichia-expressed recombinant Pfs25 with a molecular mass of 18,713 Daltons. The Pfs25M-EPA was formulated as conjugated Pfs25M in 4 mM PBS to a 2X dilution of the high dose (188 μg/ml in 0.5 ml volume) in cGMP compliance at WRB facility in Apr 2016 and was provided as a single use vial.
Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
Normal Saline: Sterile isotonic (0.9%) normal saline will be commercially procured in the US and shipped to Mali at ambient temperature. Normal saline was administered in a 0.5 mL dose as an intramuscular injection. Normal saline was be used for diluting Pfs25M-EPA and Pfs230D1M-EPA prior to formulation with AS01B for the lower dose groups in Bamako, Mali.
|
Pilot/Safety Arm 3b: Dosing Interval 0, 28, 168 Days
Participants received 3 doses of 47 μg Pfs25M-EPA/AS01 and 40 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, 168
Pfs25M-EPA: The PpPfs25M and EcEPA lots, both manufactured at Walter Reed Bioproduction facility (Silver Spring, Maryland) in cGMP compliance, were used to manufacture the conjugate. PpPfs25M is a Pichia-expressed recombinant Pfs25 with a molecular mass of 18,713 Daltons. The Pfs25M-EPA was formulated as conjugated Pfs25M in 4 mM PBS to a 2X dilution of the high dose (188 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
|
Pilot/Safety Comparator Arm 4a: Dosing Interval 0, 28, 168 Days
Participants received 3 doses of ENGERIX-B via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, and 168
Engerix-B: ENGERIX-B (hepatitis B vaccine; recombinant): is a sterile suspension of noninfectious hepatitis B virus surface antigen (HBsAg) for intramuscular administration. It contains purified HBsAg obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. Each 1-mL adult dose contains 20 g of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide. FDA approved for persons 20 years of age and older for a series of 3 doses on a 0-, 1-, 6-month schedule.
Normal Saline: Sterile isotonic (0.9%) normal saline was commercially procured in the US and shipped to Mali at ambient temperature. Normal saline was administered in a 0.5 mL dose as an intramuscular injection. Normal saline was also used for diluting Pfs25M-EPA and Pfs230D1M-EPA prior to formulation with AS01B for the lower dose groups in Bamako, Mali.
|
Pilot/Safety Comparator Arm 4b: Dosing Interval 0, 28, 168 Days
Participants received 3 doses of ENGERIX-B via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, and 168
Engerix-B: ENGERIX-B (hepatitis B vaccine; recombinant): is a sterile suspension of noninfectious hepatitis B virus surface antigen (HBsAg) for intramuscular administration. It contains purified HBsAg obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. Each 1-mL adult dose contains 20 g of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide. FDA approved for persons 20 years of age and older for a series of 3 doses on a 0-, 1-, 6-month schedule.
Coartem: Artemether/lumefantrine (Coartem(R)) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used to treat malaria. Subjects who may have had any contraindications to the use of these drugs were excluded at screening. Coartem was dosed with food and administered over 3 days for a total of 6 doses, as per package insert and standard adult dosing
|
Safety Comparator & Efficacy Comparator Arm 4c: Dosing Interval 0, 28, 168, 476 Days
Participants received 3 doses of ENGERIX-B via on Days 0, 28, and 168, then 4th vaccination of Menactra® on Day 476 (Year 2) via intramuscular injections into the deltoid muscle (IM). Participants received antimalarial drug treatment with Coartem® approximately 1 week prior to first vaccination.
Engerix-B: ENGERIX-B (hepatitis B vaccine; recombinant): is a sterile suspension of noninfectious hepatitis B virus surface antigen (HBsAg) for intramuscular administration. It contains purified HBsAg obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. Each 1-mL adult dose contains 20 g of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide.
Menactra: Menactra is FDA approved for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 (but does not protect against serotype B) for use in individuals 9 months through 55 years of age
Coartem: Artemether/lumefantrine (Coartem®) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used to treat malaria. Subjects who may have had any contraindications to the use of these drugs were excluded at screening. Coartem was dosed with food and administered over 3 days for a total of 6 doses, as per package insert and standard adult dosing
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Year 1
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
3
|
0
|
1
|
0
|
0
|
3
|
|
Year 1
Travel
|
0
|
1
|
0
|
0
|
4
|
5
|
0
|
0
|
0
|
0
|
8
|
|
Year 1
Joined Army
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Year 1
Subject met withdrawal criteria
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Year 1
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Year 1
Protocol Violation
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
2
|
|
Year 1
Pregnancy
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Year 2
Lost to Follow-up
|
0
|
0
|
0
|
0
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Year 2
Did not rescreen
|
0
|
0
|
1
|
1
|
9
|
6
|
0
|
1
|
0
|
0
|
21
|
|
Year 2
Met withdrawal criteria
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
1
|
|
Year 2
Travel
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
3
|
|
Year 2
Non-compliant
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Year 2
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Immunogenicity of Pfs25M-EPA/AS01 and Pfs230D1M-EPA/AS01 Vaccines, Transmission Blocking Vaccines Against Plasmodium Falciparum, at Full and Fractional Dosing in Adults in Mali
Baseline characteristics by cohort
| Measure |
Pilot/Safety Arm 1a: Dosing Interval 0, 28, 168 Days
n=5 Participants
Participants received 3 doses of 16 μg Pfs25M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168
|
Pilot/Safety Arm 1b: Dosing Interval 0, 28, 168 Days
n=10 Participants
Participants received 3 doses of 47 μg Pfs25M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168
|
Pilot/Safety Arm 2a: Dosing Interval 0, 28, 168 Days
n=5 Participants
Participants received 3 doses of 13 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168
|
Pilot/Safety Arm 2b: Dosing Interval 0, 28, 168 Days
n=10 Participants
Participants received 3 doses of 40 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168
|
Safety/Efficacy Arm 2c: Dosing Interval 0, 28, 168, 476 Days
n=56 Participants
Participants received 3 doses of 40 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, 168, and a 4th dose on Day 476 (Year 2). Participants received antimalarial drug treatment with Coartem® approximately 1 week prior to first vaccination.
|
Safety/Efficacy Arm 2d: Dosing Interval 0, 28, 168, 476 Days
n=61 Participants
Participants received 3 doses of 40 μg Pfs230D1M-EPA/AS01 on Days 0, 28, then 8 μg Pfs230D1M-EPA/AS01 (100 µL TBV + AS01; fractional dose) on Day 168, then 4th dose of 40 μg Pfs230D1M-EPA/AS01 on Day 476 (Year 2) via intramuscular injections into the deltoid muscle (IM). Participants received antimalarial drug treatment with Coartem® approximately 1 week prior to first vaccination.
|
Pilot/Safety Arm 3a: Dosing Interval 0, 28, 168 Days
n=5 Participants
Participants received 3 doses of 16 μg Pfs25M-EPA/AS01 and 13 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, 168
|
Pilot/Safety Arm 3b: Dosing Interval 0, 28, 168 Days
n=10 Participants
Participants received 3 doses of 47 μg Pfs25M-EPA/AS01 and 40 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, 168
|
Pilot/Safety Comparator Arm 4a: Dosing Interval 0, 28, 168 Days
n=10 Participants
Participants received 3 doses of ENGERIX-B via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, and 168
|
Pilot/Safety Comparator Arm 4b: Dosing Interval 0, 28, 168 Days
n=10 Participants
Participants received 3 doses of ENGERIX-B via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, and 168
|
Safety Comparator & Efficacy Comparator Arm 4c: Dosing Interval 0, 28, 168, 476 Days
n=119 Participants
Participants received 3 doses of ENGERIX-B via on Days 0, 28, and 168, then 4th vaccination of Menactra® on Day 476 (Year 2) via intramuscular injections into the deltoid muscle (IM). Participants received antimalarial drug treatment with Coartem® approximately 1 week prior to first vaccination.
|
Total
n=301 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
61 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
10 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
119 Participants
n=42 Participants
|
301 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
41 Participants
n=42 Participants
|
96 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
44 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
78 Participants
n=42 Participants
|
205 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Bambara
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
27 Participants
n=42 Participants
|
91 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Bozo
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Malinke
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
24 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
56 Participants
n=42 Participants
|
111 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Peulh
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
22 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Sarakole
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
25 Participants
n=42 Participants
|
55 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Sonrhai
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
17 Participants
n=42 Participants
|
|
Region of Enrollment
Mali
|
5 participants
n=5 Participants
|
10 participants
n=7 Participants
|
5 participants
n=5 Participants
|
10 participants
n=4 Participants
|
56 participants
n=21 Participants
|
61 participants
n=8 Participants
|
5 participants
n=8 Participants
|
10 participants
n=24 Participants
|
10 participants
n=42 Participants
|
10 participants
n=42 Participants
|
119 participants
n=42 Participants
|
301 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after each vaccinationNumber of participants with local and systemic adverse events (AEs) graded by severity occurring within 7 days after each vaccine
Outcome measures
| Measure |
Pilot/Safety Arm 1a: Dosing Interval 0, 28, 168 Days
n=5 Participants
Participants received 3 doses of 16 μg Pfs25M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168
Pfs25M-EPA: The PpPfs25M and EcEPA lots, both manufactured at Walter Reed Bioproduction facility (Silver Spring, Maryland) in cGMP compliance, were used to manufacture the conjugate. PpPfs25M is a Pichia- expressed recombinant Pfs25 with a molecular mass of 18,713 Daltons.
The Pfs25M- EPA was formulated as conjugated Pfs25M in 4 mM PBS to a 2X dilution of the high dose (188 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
Normal Saline: Sterile isotonic (0.9%) normal saline was commercially procured in the US and shipped to Mali at ambient temperature. Normal saline was administered in a 0.5 mL dose as an intramuscular injection. Normal saline was also used for diluting Pfs25M-EPA and Pfs230D1M-EPA prior to formulation with AS01B for the lower dose groups in Bamako, Mali.
|
Pilot/Safety Arm 1b: Dosing Interval 0, 28, 168 Days
n=10 Participants
Participants received 3 doses of 47 μg Pfs25M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168
Pfs25M-EPA: The PpPfs25M and EcEPA lots, both manufactured at Walter Reed Bioproduction facility (Silver Spring, Maryland) in cGMP compliance, were used to manufacture the conjugate. PpPfs25M is a Pichia- expressed recombinant Pfs25 with a molecular mass of 18,713 Daltons.
The Pfs25M- EPA was formulated as conjugated Pfs25M in 4 mM PBS to a 2X dilution of the high dose (188 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
|
Pilot/Safety Arm 2a: Dosing Interval 0, 28, 168 Days
n=5 Participants
Participants received 3 doses of 13 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168
Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
Normal Saline: Sterile isotonic (0.9%) normal saline was commercially procured in the US and shipped to Mali at ambient temperature. Normal saline was administered in a 0.5 mL dose as an intramuscular injection. Normal saline was used for diluting Pfs25M-EPA and Pfs230D1M-EPA prior to formulation with AS01B for the lower dose groups in Bamako, Mali.
|
Pilot/Safety Arm 2b: Dosing Interval 0, 28, 168 Days
n=10 Participants
Participants received 3 doses of 40 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168
Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
|
Safety/Efficacy Arm 2c: Dosing Interval 0, 28, 168, 476 Days
n=56 Participants
Participants received 3 doses of 40 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, 168, and a 4th dose on Day 476 (Year 2). Participants received antimalarial drug treatment with Coartem® approximately 1 week prior to first vaccination.
Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 (Micro)g/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 microgram/mL MPL and 100 microgram/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
Coartem: Artemether/lumefantrine (Coartem(R)) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used to treat malaria. Subjects who may have had any contraindications to the use of these drugs were excluded at screening. Coartem was dosed with food and administered over 3 days for a total of 6 doses, as per package insert and standard adult dosing
|
Safety/Efficacy Arm 2d: Dosing Interval 0, 28, 168, 476 Days
n=61 Participants
Participants received 3 doses of 40 μg Pfs230D1M-EPA/AS01 on Days 0, 28, then 8 μg Pfs230D1M-EPA/AS01 (100 µL TBV + AS01; fractional dose) on Day 168, then 4th dose of 40 μg Pfs230D1M-EPA/AS01 on Day 476 (Year 2) via intramuscular injections into the deltoid muscle (IM). Participants received antimalarial drug treatment with Coartem® approximately 1 week prior to first vaccination.
Participants underwent antimalarial drug treatment with Coartem on D-7 (prior to vaccination #1); 4th vaccination on D476
Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
Coartem: Artemether/lumefantrine (Coartem(R)) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used to treat malaria. Subjects who may have had any contraindications to the use of these drugs were excluded at screening. Coartem was dosed with food and administered over 3 days for a total of 6 doses, as per package insert and standard adult dosing
|
Pilot/Safety Arm 3a: Dosing Interval 0, 28, 168 Days
n=5 Participants
Participants received 3 doses of 16 μg Pfs25M-EPA/AS01 and 13 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, 168
Pfs25M-EPA: The PpPfs25M and EcEPA lots, both manufactured at Walter Reed Bioproduction facility (WRB; Silver Spring, Maryland) in cGMP compliance, were used to manufacture the conjugate. PpPfs25M is a Pichia- expressed recombinant Pfs25 with a molecular mass of 18,713 Daltons. The Pfs25M-EPA was formulated as conjugated Pfs25M in 4 mM PBS to a 2X dilution of the high dose (188 μg/ml in 0.5 ml volume) in cGMP compliance at WRB facility in Apr 2016 and provided as a single use vial.
Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and provided as a single use vial.
AS01: AS01B adjuvant will also be provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
Normal Saline: Sterile isotonic (0.9%) normal saline will be commercially procured in the US and shipped to Mali at ambient temperature. Normal saline was administered in a 0.5 mL dose as an intramuscular injection. Normal saline was be used for diluting Pfs25M-EPA and Pfs230D1M-EPA prior to formulation with AS01B for the lower dose groups in Bamako, Mali.
|
Pilot/Safety Arm 3b: Dosing Interval 0, 28, 168 Days
n=10 Participants
Participants received 3 doses of 47 μg Pfs25M-EPA/AS01 and 40 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, 168
Pfs25M-EPA: The PpPfs25M and EcEPA lots, both manufactured at Walter Reed Bioproduction facility (Silver Spring, Maryland) in cGMP compliance, were used to manufacture the conjugate. PpPfs25M is a Pichia-expressed recombinant Pfs25 with a molecular mass of 18,713 Daltons.The Pfs25M-EPA was formulated as conjugated Pfs25M in 4 mM PBS to a 2X dilution of the high dose (188 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
|
Pilot/Safety Comparator Arm 4a: Dosing Interval 0, 28, 168 Days
n=10 Participants
Participants received 3 doses of ENGERIX-B via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, and 168
Engerix-B: ENGERIX-B (hepatitis B vaccine; recombinant): is a sterile suspension of noninfectious hepatitis B virus surface antigen (HBsAg) for intramuscular administration. It contains purified HBsAg obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. Each 1-mL adult dose contains 20 g of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide. FDA approved for persons 20 years of age and older for a series of 3 doses on a 0-, 1-, 6-month schedule.
Normal Saline: Sterile isotonic (0.9%) normal saline was commercially procured in the US and shipped to Mali at ambient temperature. Normal saline was administered in a 0.5 mL dose as an intramuscular injection. Normal saline was also used for diluting Pfs25M-EPA and Pfs230D1M-EPA prior to formulation with AS01B for the lower dose groups in Bamako, Mali.
|
Pilot/Safety Comparator Arm 4b: Dosing Interval 0, 28, 168 Days
n=10 Participants
Participants received 3 doses of ENGERIX-B via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, and 168
Engerix-B: ENGERIX-B (hepatitis B vaccine; recombinant): is a sterile suspension of noninfectious hepatitis B virus surface antigen (HBsAg) for intramuscular administration. It contains purified HBsAg obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. Each 1-mL adult dose contains 20 g of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide. FDA approved for persons 20 years of age and older for a series of 3 doses on a 0-, 1-, 6-month schedule.
Coartem: Artemether/lumefantrine (Coartem(R)) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used to treat malaria. Subjects who may have had any contraindications to the use of these drugs were excluded at screening. Coartem was dosed with food and administered over 3 days for a total of 6 doses, as per package insert and standard adult dosing
|
Safety Comparator & Efficacy Comparator Arm 4c: Dosing Interval 0, 28, 168, 476 Days
n=119 Participants
Participants received 3 doses of ENGERIX-B via on Days 0, 28, and 168, then 4th vaccination of Menactra® on Day 476 (Year 2) via intramuscular injections into the deltoid muscle (IM). Participants received antimalarial drug treatment with Coartem® approximately 1 week prior to first vaccination.
Engerix-B: ENGERIX-B (hepatitis B vaccine; recombinant): is a sterile suspension of noninfectious hepatitis B virus surface antigen (HBsAg) for intramuscular administration. It contains purified HBsAg obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. Each 1-mL adult dose contains 20 g of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide.
Menactra: Menactra is FDA approved for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 (but does not protect against serotype B) for use in individuals 9 months through 55 years of age
Coartem: Artemether/lumefantrine (Coartem®) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used to treat malaria. Subjects who may have had any contraindications to the use of these drugs were excluded at screening. Coartem was dosed with food and administered over 3 days for a total of 6 doses, as per package insert and standard adult dosing
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Local and Systemic Adverse Events in Year 1
|
2 Participants
|
6 Participants
|
4 Participants
|
6 Participants
|
31 Participants
|
25 Participants
|
3 Participants
|
8 Participants
|
2 Participants
|
3 Participants
|
52 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after each vaccinationNumber of participants with local and systemic adverse events (AEs) graded by severity occurring within 7 days after each vaccine
Outcome measures
| Measure |
Pilot/Safety Arm 1a: Dosing Interval 0, 28, 168 Days
n=56 Participants
Participants received 3 doses of 16 μg Pfs25M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168
Pfs25M-EPA: The PpPfs25M and EcEPA lots, both manufactured at Walter Reed Bioproduction facility (Silver Spring, Maryland) in cGMP compliance, were used to manufacture the conjugate. PpPfs25M is a Pichia- expressed recombinant Pfs25 with a molecular mass of 18,713 Daltons.
The Pfs25M- EPA was formulated as conjugated Pfs25M in 4 mM PBS to a 2X dilution of the high dose (188 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
Normal Saline: Sterile isotonic (0.9%) normal saline was commercially procured in the US and shipped to Mali at ambient temperature. Normal saline was administered in a 0.5 mL dose as an intramuscular injection. Normal saline was also used for diluting Pfs25M-EPA and Pfs230D1M-EPA prior to formulation with AS01B for the lower dose groups in Bamako, Mali.
|
Pilot/Safety Arm 1b: Dosing Interval 0, 28, 168 Days
n=61 Participants
Participants received 3 doses of 47 μg Pfs25M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168
Pfs25M-EPA: The PpPfs25M and EcEPA lots, both manufactured at Walter Reed Bioproduction facility (Silver Spring, Maryland) in cGMP compliance, were used to manufacture the conjugate. PpPfs25M is a Pichia- expressed recombinant Pfs25 with a molecular mass of 18,713 Daltons.
The Pfs25M- EPA was formulated as conjugated Pfs25M in 4 mM PBS to a 2X dilution of the high dose (188 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
|
Pilot/Safety Arm 2a: Dosing Interval 0, 28, 168 Days
n=119 Participants
Participants received 3 doses of 13 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168
Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
Normal Saline: Sterile isotonic (0.9%) normal saline was commercially procured in the US and shipped to Mali at ambient temperature. Normal saline was administered in a 0.5 mL dose as an intramuscular injection. Normal saline was used for diluting Pfs25M-EPA and Pfs230D1M-EPA prior to formulation with AS01B for the lower dose groups in Bamako, Mali.
|
Pilot/Safety Arm 2b: Dosing Interval 0, 28, 168 Days
Participants received 3 doses of 40 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168
Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
|
Safety/Efficacy Arm 2c: Dosing Interval 0, 28, 168, 476 Days
Participants received 3 doses of 40 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, 168, and a 4th dose on Day 476 (Year 2). Participants received antimalarial drug treatment with Coartem® approximately 1 week prior to first vaccination.
Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 (Micro)g/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 microgram/mL MPL and 100 microgram/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
Coartem: Artemether/lumefantrine (Coartem(R)) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used to treat malaria. Subjects who may have had any contraindications to the use of these drugs were excluded at screening. Coartem was dosed with food and administered over 3 days for a total of 6 doses, as per package insert and standard adult dosing
|
Safety/Efficacy Arm 2d: Dosing Interval 0, 28, 168, 476 Days
Participants received 3 doses of 40 μg Pfs230D1M-EPA/AS01 on Days 0, 28, then 8 μg Pfs230D1M-EPA/AS01 (100 µL TBV + AS01; fractional dose) on Day 168, then 4th dose of 40 μg Pfs230D1M-EPA/AS01 on Day 476 (Year 2) via intramuscular injections into the deltoid muscle (IM). Participants received antimalarial drug treatment with Coartem® approximately 1 week prior to first vaccination.
Participants underwent antimalarial drug treatment with Coartem on D-7 (prior to vaccination #1); 4th vaccination on D476
Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
Coartem: Artemether/lumefantrine (Coartem(R)) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used to treat malaria. Subjects who may have had any contraindications to the use of these drugs were excluded at screening. Coartem was dosed with food and administered over 3 days for a total of 6 doses, as per package insert and standard adult dosing
|
Pilot/Safety Arm 3a: Dosing Interval 0, 28, 168 Days
Participants received 3 doses of 16 μg Pfs25M-EPA/AS01 and 13 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, 168
Pfs25M-EPA: The PpPfs25M and EcEPA lots, both manufactured at Walter Reed Bioproduction facility (WRB; Silver Spring, Maryland) in cGMP compliance, were used to manufacture the conjugate. PpPfs25M is a Pichia- expressed recombinant Pfs25 with a molecular mass of 18,713 Daltons. The Pfs25M-EPA was formulated as conjugated Pfs25M in 4 mM PBS to a 2X dilution of the high dose (188 μg/ml in 0.5 ml volume) in cGMP compliance at WRB facility in Apr 2016 and provided as a single use vial.
Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and provided as a single use vial.
AS01: AS01B adjuvant will also be provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
Normal Saline: Sterile isotonic (0.9%) normal saline will be commercially procured in the US and shipped to Mali at ambient temperature. Normal saline was administered in a 0.5 mL dose as an intramuscular injection. Normal saline was be used for diluting Pfs25M-EPA and Pfs230D1M-EPA prior to formulation with AS01B for the lower dose groups in Bamako, Mali.
|
Pilot/Safety Arm 3b: Dosing Interval 0, 28, 168 Days
Participants received 3 doses of 47 μg Pfs25M-EPA/AS01 and 40 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, 168
Pfs25M-EPA: The PpPfs25M and EcEPA lots, both manufactured at Walter Reed Bioproduction facility (Silver Spring, Maryland) in cGMP compliance, were used to manufacture the conjugate. PpPfs25M is a Pichia-expressed recombinant Pfs25 with a molecular mass of 18,713 Daltons.The Pfs25M-EPA was formulated as conjugated Pfs25M in 4 mM PBS to a 2X dilution of the high dose (188 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
|
Pilot/Safety Comparator Arm 4a: Dosing Interval 0, 28, 168 Days
Participants received 3 doses of ENGERIX-B via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, and 168
Engerix-B: ENGERIX-B (hepatitis B vaccine; recombinant): is a sterile suspension of noninfectious hepatitis B virus surface antigen (HBsAg) for intramuscular administration. It contains purified HBsAg obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. Each 1-mL adult dose contains 20 g of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide. FDA approved for persons 20 years of age and older for a series of 3 doses on a 0-, 1-, 6-month schedule.
Normal Saline: Sterile isotonic (0.9%) normal saline was commercially procured in the US and shipped to Mali at ambient temperature. Normal saline was administered in a 0.5 mL dose as an intramuscular injection. Normal saline was also used for diluting Pfs25M-EPA and Pfs230D1M-EPA prior to formulation with AS01B for the lower dose groups in Bamako, Mali.
|
Pilot/Safety Comparator Arm 4b: Dosing Interval 0, 28, 168 Days
Participants received 3 doses of ENGERIX-B via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, and 168
Engerix-B: ENGERIX-B (hepatitis B vaccine; recombinant): is a sterile suspension of noninfectious hepatitis B virus surface antigen (HBsAg) for intramuscular administration. It contains purified HBsAg obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. Each 1-mL adult dose contains 20 g of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide. FDA approved for persons 20 years of age and older for a series of 3 doses on a 0-, 1-, 6-month schedule.
Coartem: Artemether/lumefantrine (Coartem(R)) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used to treat malaria. Subjects who may have had any contraindications to the use of these drugs were excluded at screening. Coartem was dosed with food and administered over 3 days for a total of 6 doses, as per package insert and standard adult dosing
|
Safety Comparator & Efficacy Comparator Arm 4c: Dosing Interval 0, 28, 168, 476 Days
Participants received 3 doses of ENGERIX-B via on Days 0, 28, and 168, then 4th vaccination of Menactra® on Day 476 (Year 2) via intramuscular injections into the deltoid muscle (IM). Participants received antimalarial drug treatment with Coartem® approximately 1 week prior to first vaccination.
Engerix-B: ENGERIX-B (hepatitis B vaccine; recombinant): is a sterile suspension of noninfectious hepatitis B virus surface antigen (HBsAg) for intramuscular administration. It contains purified HBsAg obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. Each 1-mL adult dose contains 20 g of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide.
Menactra: Menactra is FDA approved for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 (but does not protect against serotype B) for use in individuals 9 months through 55 years of age
Coartem: Artemether/lumefantrine (Coartem®) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used to treat malaria. Subjects who may have had any contraindications to the use of these drugs were excluded at screening. Coartem was dosed with food and administered over 3 days for a total of 6 doses, as per package insert and standard adult dosing
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Local and Systemic Adverse Events in Year 2
|
28 Participants
|
27 Participants
|
20 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Pilot/Safety Arm 1a: Dosing Interval 0, 28, 168 Days
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Pilot/Safety Arm 1b: Dosing Interval 0, 28, 168 Days
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Pilot/Safety Arm 2a: Dosing Interval 0, 28, 168 Days
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Pilot/Safety Arm 2b: Dosing Interval 0, 28, 168 Days
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Safety/Efficacy Arm 2c: Dosing Interval 0, 28, 168, 476 Days
Serious events: 0 serious events
Other events: 53 other events
Deaths: 0 deaths
Safety/Efficacy Arm 2d: Dosing Interval 0, 28, 168, 476 Days
Serious events: 0 serious events
Other events: 58 other events
Deaths: 0 deaths
Pilot/Safety Arm 3a: Dosing Interval 0, 28, 168 Days
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Pilot/Safety Arm 3b: Dosing Interval 0, 28, 168 Days
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Pilot/Safety Comparator Arm 4a: Dosing Interval 0, 28, 168 Days
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Pilot/Safety Comparator Arm 4b: Dosing Interval 0, 28, 168 Days
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Safety Comparator & Efficacy Comparator Arm 4c: Dosing Interval 0, 28, 168, 476 Days
Serious events: 1 serious events
Other events: 79 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pilot/Safety Arm 1a: Dosing Interval 0, 28, 168 Days
n=5 participants at risk
Participants received 3 doses of 16 μg Pfs25M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168
Pfs25M-EPA: The PpPfs25M and EcEPA lots, both manufactured at Walter Reed Bioproduction facility (Silver Spring, Maryland) in cGMP compliance, were used to manufacture the conjugate. PpPfs25M is a Pichia- expressed recombinant Pfs25 with a molecular mass of 18,713 Daltons.
The Pfs25M- EPA was formulated as conjugated Pfs25M in 4 mM PBS to a 2X dilution of the high dose (188 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
Normal Saline: Sterile isotonic (0.9%) normal saline was commercially procured in the US and shipped to Mali at ambient temperature. Normal saline was administered in a 0.5 mL dose as an intramuscular injection. Normal saline was also used for diluting Pfs25M-EPA and Pfs230D1M-EPA prior to formulation with AS01B for the lower dose groups in Bamako, Mali.
|
Pilot/Safety Arm 1b: Dosing Interval 0, 28, 168 Days
n=10 participants at risk
Participants received 3 doses of 47 μg Pfs25M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168
Pfs25M-EPA: The PpPfs25M and EcEPA lots, both manufactured at Walter Reed Bioproduction facility (Silver Spring, Maryland) in cGMP compliance, were used to manufacture the conjugate. PpPfs25M is a Pichia- expressed recombinant Pfs25 with a molecular mass of 18,713 Daltons.
The Pfs25M- EPA was formulated as conjugated Pfs25M in 4 mM PBS to a 2X dilution of the high dose (188 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
|
Pilot/Safety Arm 2a: Dosing Interval 0, 28, 168 Days
n=5 participants at risk
Participants received 3 doses of 13 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168
Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
Normal Saline: Sterile isotonic (0.9%) normal saline was commercially procured in the US and shipped to Mali at ambient temperature. Normal saline was administered in a 0.5 mL dose as an intramuscular injection. Normal saline was used for diluting Pfs25M-EPA and Pfs230D1M-EPA prior to formulation with AS01B for the lower dose groups in Bamako, Mali.
|
Pilot/Safety Arm 2b: Dosing Interval 0, 28, 168 Days
n=10 participants at risk
Participants received 3 doses of 40 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168
Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
|
Safety/Efficacy Arm 2c: Dosing Interval 0, 28, 168, 476 Days
n=56 participants at risk
Participants received 3 doses of 40 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, 168, and a 4th dose on Day 476 (Year 2). Participants received antimalarial drug treatment with Coartem® approximately 1 week prior to first vaccination.
Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 (Micro)g/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 microgram/mL MPL and 100 microgram/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
Coartem: Artemether/lumefantrine (Coartem(R)) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used to treat malaria. Subjects who may have had any contraindications to the use of these drugs were excluded at screening. Coartem was dosed with food and administered over 3 days for a total of 6 doses, as per package insert and standard adult dosing
|
Safety/Efficacy Arm 2d: Dosing Interval 0, 28, 168, 476 Days
n=61 participants at risk
Participants received 3 doses of 40 μg Pfs230D1M-EPA/AS01 on Days 0, 28, then 8 μg Pfs230D1M-EPA/AS01 (100 µL TBV + AS01; fractional dose) on Day 168, then 4th dose of 40 μg Pfs230D1M-EPA/AS01 on Day 476 (Year 2) via intramuscular injections into the deltoid muscle (IM). Participants received antimalarial drug treatment with Coartem® approximately 1 week prior to first vaccination.
Participants underwent antimalarial drug treatment with Coartem on D-7 (prior to vaccination #1); 4th vaccination on D476
Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
Coartem: Artemether/lumefantrine (Coartem(R)) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used to treat malaria. Subjects who may have had any contraindications to the use of these drugs were excluded at screening. Coartem was dosed with food and administered over 3 days for a total of 6 doses, as per package insert and standard adult dosing
|
Pilot/Safety Arm 3a: Dosing Interval 0, 28, 168 Days
n=5 participants at risk
Participants received 3 doses of 16 μg Pfs25M-EPA/AS01 and 13 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, 168
Pfs25M-EPA: The PpPfs25M and EcEPA lots, both manufactured at Walter Reed Bioproduction facility (WRB; Silver Spring, Maryland) in cGMP compliance, were used to manufacture the conjugate. PpPfs25M is a Pichia- expressed recombinant Pfs25 with a molecular mass of 18,713 Daltons. The Pfs25M-EPA was formulated as conjugated Pfs25M in 4 mM PBS to a 2X dilution of the high dose (188 μg/ml in 0.5 ml volume) in cGMP compliance at WRB facility in April 2016 and was provided as a single use vial.
Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at WRB facility in April 2016 and was provided as a single use vial.
AS01: AS01B adjuvant will also be provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
Normal Saline: Sterile isotonic (0.9%) normal saline will be commercially procured in the US and shipped to Mali at ambient temperature. Normal saline was administered in a 0.5 mL dose as an intramuscular injection. Normal saline was be used for diluting Pfs25M-EPA and Pfs230D1M-EPA prior to formulation with AS01B for the lower dose groups in Bamako, Mali.
|
Pilot/Safety Arm 3b: Dosing Interval 0, 28, 168 Days
n=10 participants at risk
Participants received 3 doses of 47 μg Pfs25M-EPA/AS01 and 40 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, 168
Pfs25M-EPA: The PpPfs25M and EcEPA lots, both manufactured at Walter Reed Bioproduction facility (Silver Spring, Maryland) in cGMP compliance, were used to manufacture the conjugate. PpPfs25M is a Pichia-expressed recombinant Pfs25 with a molecular mass of 18,713 Daltons.The Pfs25M-EPA was formulated as conjugated Pfs25M in 4 mM PBS to a 2X dilution of the high dose (188 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
|
Pilot/Safety Comparator Arm 4a: Dosing Interval 0, 28, 168 Days
n=10 participants at risk
Participants received 3 doses of ENGERIX-B via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, and 168
Engerix-B: ENGERIX-B (hepatitis B vaccine; recombinant): is a sterile suspension of noninfectious hepatitis B virus surface antigen (HBsAg) for intramuscular administration. It contains purified HBsAg obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. Each 1-mL adult dose contains 20 g of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide. FDA approved for persons 20 years of age and older for a series of 3 doses on a 0-, 1-, 6-month schedule.
Normal Saline: Sterile isotonic (0.9%) normal saline was commercially procured in the US and shipped to Mali at ambient temperature. Normal saline was administered in a 0.5 mL dose as an intramuscular injection. Normal saline was also used for diluting Pfs25M-EPA and Pfs230D1M-EPA prior to formulation with AS01B for the lower dose groups in Bamako, Mali.
|
Pilot/Safety Comparator Arm 4b: Dosing Interval 0, 28, 168 Days
n=10 participants at risk
Participants received 3 doses of ENGERIX-B via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, and 168
Engerix-B: ENGERIX-B (hepatitis B vaccine; recombinant): is a sterile suspension of noninfectious hepatitis B virus surface antigen (HBsAg) for intramuscular administration. It contains purified HBsAg obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. Each 1-mL adult dose contains 20 g of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide. FDA approved for persons 20 years of age and older for a series of 3 doses on a 0-, 1-, 6-month schedule.
Coartem: Artemether/lumefantrine (Coartem(R)) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used to treat malaria. Subjects who may have had any contraindications to the use of these drugs were excluded at screening. Coartem was dosed with food and administered over 3 days for a total of 6 doses, as per package insert and standard adult dosing
|
Safety Comparator & Efficacy Comparator Arm 4c: Dosing Interval 0, 28, 168, 476 Days
n=119 participants at risk
Participants received 3 doses of ENGERIX-B via on Days 0, 28, and 168, then 4th vaccination of Menactra® on Day 476 (Year 2) via intramuscular injections into the deltoid muscle (IM). Participants received antimalarial drug treatment with Coartem® approximately 1 week prior to first vaccination.
Engerix-B: ENGERIX-B (hepatitis B vaccine; recombinant): is a sterile suspension of noninfectious hepatitis B virus surface antigen (HBsAg) for intramuscular administration. It contains purified HBsAg obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. Each 1-mL adult dose contains 20 g of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide.
Menactra: Menactra is FDA approved for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 (but does not protect against serotype B) for use in individuals 9 months through 55 years of age
Coartem: Artemether/lumefantrine (Coartem®) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used to treat malaria. Subjects who may have had any contraindications to the use of these drugs were excluded at screening. Coartem was dosed with food and administered over 3 days for a total of 6 doses, as per package insert and standard adult dosing
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Pulmonary Tuberculosis
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/56 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/61 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
10.0%
1/10 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/119 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Injury, poisoning and procedural complications
Snake Bite
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/56 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/61 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.84%
1/119 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
Other adverse events
| Measure |
Pilot/Safety Arm 1a: Dosing Interval 0, 28, 168 Days
n=5 participants at risk
Participants received 3 doses of 16 μg Pfs25M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168
Pfs25M-EPA: The PpPfs25M and EcEPA lots, both manufactured at Walter Reed Bioproduction facility (Silver Spring, Maryland) in cGMP compliance, were used to manufacture the conjugate. PpPfs25M is a Pichia- expressed recombinant Pfs25 with a molecular mass of 18,713 Daltons.
The Pfs25M- EPA was formulated as conjugated Pfs25M in 4 mM PBS to a 2X dilution of the high dose (188 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
Normal Saline: Sterile isotonic (0.9%) normal saline was commercially procured in the US and shipped to Mali at ambient temperature. Normal saline was administered in a 0.5 mL dose as an intramuscular injection. Normal saline was also used for diluting Pfs25M-EPA and Pfs230D1M-EPA prior to formulation with AS01B for the lower dose groups in Bamako, Mali.
|
Pilot/Safety Arm 1b: Dosing Interval 0, 28, 168 Days
n=10 participants at risk
Participants received 3 doses of 47 μg Pfs25M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168
Pfs25M-EPA: The PpPfs25M and EcEPA lots, both manufactured at Walter Reed Bioproduction facility (Silver Spring, Maryland) in cGMP compliance, were used to manufacture the conjugate. PpPfs25M is a Pichia- expressed recombinant Pfs25 with a molecular mass of 18,713 Daltons.
The Pfs25M- EPA was formulated as conjugated Pfs25M in 4 mM PBS to a 2X dilution of the high dose (188 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
|
Pilot/Safety Arm 2a: Dosing Interval 0, 28, 168 Days
n=5 participants at risk
Participants received 3 doses of 13 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168
Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
Normal Saline: Sterile isotonic (0.9%) normal saline was commercially procured in the US and shipped to Mali at ambient temperature. Normal saline was administered in a 0.5 mL dose as an intramuscular injection. Normal saline was used for diluting Pfs25M-EPA and Pfs230D1M-EPA prior to formulation with AS01B for the lower dose groups in Bamako, Mali.
|
Pilot/Safety Arm 2b: Dosing Interval 0, 28, 168 Days
n=10 participants at risk
Participants received 3 doses of 40 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on D0, D28, D168
Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
|
Safety/Efficacy Arm 2c: Dosing Interval 0, 28, 168, 476 Days
n=56 participants at risk
Participants received 3 doses of 40 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, 168, and a 4th dose on Day 476 (Year 2). Participants received antimalarial drug treatment with Coartem® approximately 1 week prior to first vaccination.
Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 (Micro)g/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 microgram/mL MPL and 100 microgram/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
Coartem: Artemether/lumefantrine (Coartem(R)) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used to treat malaria. Subjects who may have had any contraindications to the use of these drugs were excluded at screening. Coartem was dosed with food and administered over 3 days for a total of 6 doses, as per package insert and standard adult dosing
|
Safety/Efficacy Arm 2d: Dosing Interval 0, 28, 168, 476 Days
n=61 participants at risk
Participants received 3 doses of 40 μg Pfs230D1M-EPA/AS01 on Days 0, 28, then 8 μg Pfs230D1M-EPA/AS01 (100 µL TBV + AS01; fractional dose) on Day 168, then 4th dose of 40 μg Pfs230D1M-EPA/AS01 on Day 476 (Year 2) via intramuscular injections into the deltoid muscle (IM). Participants received antimalarial drug treatment with Coartem® approximately 1 week prior to first vaccination.
Participants underwent antimalarial drug treatment with Coartem on D-7 (prior to vaccination #1); 4th vaccination on D476
Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
Coartem: Artemether/lumefantrine (Coartem(R)) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used to treat malaria. Subjects who may have had any contraindications to the use of these drugs were excluded at screening. Coartem was dosed with food and administered over 3 days for a total of 6 doses, as per package insert and standard adult dosing
|
Pilot/Safety Arm 3a: Dosing Interval 0, 28, 168 Days
n=5 participants at risk
Participants received 3 doses of 16 μg Pfs25M-EPA/AS01 and 13 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, 168
Pfs25M-EPA: The PpPfs25M and EcEPA lots, both manufactured at Walter Reed Bioproduction facility (WRB; Silver Spring, Maryland) in cGMP compliance, were used to manufacture the conjugate. PpPfs25M is a Pichia- expressed recombinant Pfs25 with a molecular mass of 18,713 Daltons. The Pfs25M-EPA was formulated as conjugated Pfs25M in 4 mM PBS to a 2X dilution of the high dose (188 μg/ml in 0.5 ml volume) in cGMP compliance at WRB facility in April 2016 and was provided as a single use vial.
Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at WRB facility in April 2016 and was provided as a single use vial.
AS01: AS01B adjuvant will also be provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
Normal Saline: Sterile isotonic (0.9%) normal saline will be commercially procured in the US and shipped to Mali at ambient temperature. Normal saline was administered in a 0.5 mL dose as an intramuscular injection. Normal saline was be used for diluting Pfs25M-EPA and Pfs230D1M-EPA prior to formulation with AS01B for the lower dose groups in Bamako, Mali.
|
Pilot/Safety Arm 3b: Dosing Interval 0, 28, 168 Days
n=10 participants at risk
Participants received 3 doses of 47 μg Pfs25M-EPA/AS01 and 40 μg Pfs230D1M-EPA/AS01 via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, 168
Pfs25M-EPA: The PpPfs25M and EcEPA lots, both manufactured at Walter Reed Bioproduction facility (Silver Spring, Maryland) in cGMP compliance, were used to manufacture the conjugate. PpPfs25M is a Pichia-expressed recombinant Pfs25 with a molecular mass of 18,713 Daltons.The Pfs25M-EPA was formulated as conjugated Pfs25M in 4 mM PBS to a 2X dilution of the high dose (188 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
Pfs230D1M-EPA: The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 μg/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and was provided as a single use vial.
AS01: AS01B adjuvant was provided as a single use vial by GSK, 100 μg/mL MPL and 100 μg/mL QS21 in a liposomal formulation in a volume of 0.625 mL. One dose injected of AS01B corresponds to 50 μg QS21 and 50 μg MPL.
|
Pilot/Safety Comparator Arm 4a: Dosing Interval 0, 28, 168 Days
n=10 participants at risk
Participants received 3 doses of ENGERIX-B via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, and 168
Engerix-B: ENGERIX-B (hepatitis B vaccine; recombinant): is a sterile suspension of noninfectious hepatitis B virus surface antigen (HBsAg) for intramuscular administration. It contains purified HBsAg obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. Each 1-mL adult dose contains 20 g of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide. FDA approved for persons 20 years of age and older for a series of 3 doses on a 0-, 1-, 6-month schedule.
Normal Saline: Sterile isotonic (0.9%) normal saline was commercially procured in the US and shipped to Mali at ambient temperature. Normal saline was administered in a 0.5 mL dose as an intramuscular injection. Normal saline was also used for diluting Pfs25M-EPA and Pfs230D1M-EPA prior to formulation with AS01B for the lower dose groups in Bamako, Mali.
|
Pilot/Safety Comparator Arm 4b: Dosing Interval 0, 28, 168 Days
n=10 participants at risk
Participants received 3 doses of ENGERIX-B via intramuscular injections into the deltoid muscle (IM) on Days 0, 28, and 168
Engerix-B: ENGERIX-B (hepatitis B vaccine; recombinant): is a sterile suspension of noninfectious hepatitis B virus surface antigen (HBsAg) for intramuscular administration. It contains purified HBsAg obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. Each 1-mL adult dose contains 20 g of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide. FDA approved for persons 20 years of age and older for a series of 3 doses on a 0-, 1-, 6-month schedule.
Coartem: Artemether/lumefantrine (Coartem(R)) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used to treat malaria. Subjects who may have had any contraindications to the use of these drugs were excluded at screening. Coartem was dosed with food and administered over 3 days for a total of 6 doses, as per package insert and standard adult dosing
|
Safety Comparator & Efficacy Comparator Arm 4c: Dosing Interval 0, 28, 168, 476 Days
n=119 participants at risk
Participants received 3 doses of ENGERIX-B via on Days 0, 28, and 168, then 4th vaccination of Menactra® on Day 476 (Year 2) via intramuscular injections into the deltoid muscle (IM). Participants received antimalarial drug treatment with Coartem® approximately 1 week prior to first vaccination.
Engerix-B: ENGERIX-B (hepatitis B vaccine; recombinant): is a sterile suspension of noninfectious hepatitis B virus surface antigen (HBsAg) for intramuscular administration. It contains purified HBsAg obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. Each 1-mL adult dose contains 20 g of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide.
Menactra: Menactra is FDA approved for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 (but does not protect against serotype B) for use in individuals 9 months through 55 years of age
Coartem: Artemether/lumefantrine (Coartem®) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used to treat malaria. Subjects who may have had any contraindications to the use of these drugs were excluded at screening. Coartem was dosed with food and administered over 3 days for a total of 6 doses, as per package insert and standard adult dosing
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
10.0%
1/10 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/56 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/61 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/119 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
10.0%
1/10 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
3.6%
2/56 • Number of events 2 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
1.6%
1/61 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
1.7%
2/119 • Number of events 2 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
20.0%
1/5 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
5.4%
3/56 • Number of events 3 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
1.6%
1/61 • Number of events 2 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
10.0%
1/10 • Number of events 2 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
1.7%
2/119 • Number of events 2 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
20.0%
2/10 • Number of events 2 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
12.5%
7/56 • Number of events 8 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
3.3%
2/61 • Number of events 2 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
20.0%
2/10 • Number of events 2 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
10.0%
1/10 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.84%
1/119 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/56 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/61 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.84%
1/119 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Investigations
Blood creatinine increased
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
20.0%
1/5 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/56 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
1.6%
1/61 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
2.5%
3/119 • Number of events 3 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/56 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
1.6%
1/61 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/119 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
General disorders
Chills
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
7.1%
4/56 • Number of events 4 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
4.9%
3/61 • Number of events 3 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.84%
1/119 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
1.8%
1/56 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/61 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.84%
1/119 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/56 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/61 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.84%
1/119 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/56 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
1.6%
1/61 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
1.7%
2/119 • Number of events 2 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
General disorders
Decreased appetite
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/56 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/61 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.84%
1/119 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/56 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
3.3%
2/61 • Number of events 3 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
10.0%
1/10 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
10.0%
1/10 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/119 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/56 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/61 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
10.0%
1/10 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.84%
1/119 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Cardiac disorders
Diastolic hypertension
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
1.8%
1/56 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/61 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/119 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
General disorders
Dizziness
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
1.8%
1/56 • Number of events 2 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
1.6%
1/61 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
2.5%
3/119 • Number of events 3 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
General disorders
Fatigue
|
20.0%
1/5 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
10.0%
1/10 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
5.4%
3/56 • Number of events 3 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
1.6%
1/61 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
20.0%
1/5 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
10.0%
1/10 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.84%
1/119 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Skin and subcutaneous tissue disorders
Furuncle
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
1.8%
1/56 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
1.6%
1/61 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.84%
1/119 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
10.0%
1/10 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
1.8%
1/56 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
1.6%
1/61 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
2.5%
3/119 • Number of events 3 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/56 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/61 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
20.0%
1/5 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/119 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Reproductive system and breast disorders
Genital infection
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/56 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/61 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
1.7%
2/119 • Number of events 2 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
20.0%
1/5 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
40.0%
4/10 • Number of events 4 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
41.1%
23/56 • Number of events 35 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
41.0%
25/61 • Number of events 29 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
20.0%
1/5 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
50.0%
5/10 • Number of events 6 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
10.0%
1/10 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
10.0%
1/10 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
9.2%
11/119 • Number of events 15 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/56 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
1.6%
1/61 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.84%
1/119 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Blood and lymphatic system disorders
Hemoglobin increased
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/56 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/61 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.84%
1/119 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
General disorders
Injection site edema
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
3.6%
2/56 • Number of events 2 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/61 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/119 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
General disorders
Injection site induration
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
10.0%
1/10 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/56 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/61 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
10.0%
1/10 • Number of events 2 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/119 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
General disorders
Injection site movement impairment
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
20.0%
2/10 • Number of events 2 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
10.7%
6/56 • Number of events 6 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
3.3%
2/61 • Number of events 2 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
20.0%
2/10 • Number of events 4 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
2.5%
3/119 • Number of events 3 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
General disorders
Injection site pain
|
40.0%
2/5 • Number of events 3 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
70.0%
7/10 • Number of events 8 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
80.0%
4/5 • Number of events 9 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
70.0%
7/10 • Number of events 13 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
91.1%
51/56 • Number of events 137 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
78.7%
48/61 • Number of events 113 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
80.0%
4/5 • Number of events 12 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
80.0%
8/10 • Number of events 29 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
30.0%
3/10 • Number of events 3 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
31.9%
38/119 • Number of events 55 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
General disorders
Injection site pruritus
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
10.0%
1/10 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/56 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/61 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
1.7%
2/119 • Number of events 2 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
1.8%
1/56 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
1.6%
1/61 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/119 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
10.7%
6/56 • Number of events 6 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
4.9%
3/61 • Number of events 3 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
10.0%
1/10 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
7.6%
9/119 • Number of events 14 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Infections and infestations
Malaria
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
8.9%
5/56 • Number of events 5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
8.2%
5/61 • Number of events 5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
5.0%
6/119 • Number of events 6 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
7.1%
4/56 • Number of events 4 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
1.6%
1/61 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
20.0%
1/5 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.84%
1/119 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
5.4%
3/56 • Number of events 3 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
3.3%
2/61 • Number of events 2 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
2.5%
3/119 • Number of events 3 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/56 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/61 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.84%
1/119 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Blood and lymphatic system disorders
Neutropenia
|
20.0%
1/5 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
20.0%
2/10 • Number of events 3 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
30.0%
3/10 • Number of events 5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
12.5%
7/56 • Number of events 7 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
4.9%
3/61 • Number of events 3 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
10.0%
1/10 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
5.9%
7/119 • Number of events 8 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Gastrointestinal disorders
Oropharyngeal pain
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/56 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/61 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
1.7%
2/119 • Number of events 2 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
General disorders
Pain
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
1.8%
1/56 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/61 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/119 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
General disorders
Pain in extremity
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/56 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
1.6%
1/61 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/119 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Skin and subcutaneous tissue disorders
Paronychia
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/56 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/61 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
1.7%
2/119 • Number of events 2 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Gastrointestinal disorders
Pharyngitis
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/56 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
1.6%
1/61 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/119 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Investigations
Platelet count decreased
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/56 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
1.6%
1/61 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/119 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/56 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/61 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.84%
1/119 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Skin and subcutaneous tissue disorders
Pyoderma
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/56 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
1.6%
1/61 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/119 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
General disorders
Pyrexia
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
16.1%
9/56 • Number of events 10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
4.9%
3/61 • Number of events 4 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
10.0%
1/10 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
1.7%
2/119 • Number of events 2 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
20.0%
1/5 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
20.0%
2/10 • Number of events 2 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/56 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
1.6%
1/61 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
10.0%
1/10 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
10.0%
1/10 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
10.0%
1/10 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
1.7%
2/119 • Number of events 2 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
10.0%
1/10 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
20.0%
2/10 • Number of events 2 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
8.9%
5/56 • Number of events 5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
4.9%
3/61 • Number of events 3 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
10.0%
1/10 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
10.0%
1/10 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
7.6%
9/119 • Number of events 9 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Nervous system disorders
Sciatica
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/56 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/61 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.84%
1/119 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Infections and infestations
Sinobronchitis
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
3.6%
2/56 • Number of events 2 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
1.6%
1/61 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
2.5%
3/119 • Number of events 3 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Cardiac disorders
Systolic hypertension
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
1.8%
1/56 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/61 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/119 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/56 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
1.6%
1/61 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/119 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
1.8%
1/56 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
3.3%
2/61 • Number of events 2 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
20.0%
1/5 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.84%
1/119 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Endocrine disorders
Urinary tract infection
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/56 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/61 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
3.4%
4/119 • Number of events 4 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/56 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
1.6%
1/61 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/119 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/56 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/61 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.84%
1/119 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
1.8%
1/56 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/61 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/119 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
|
Skin and subcutaneous tissue disorders
Wound
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
1.8%
1/56 • Number of events 1 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
3.3%
2/61 • Number of events 2 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
0.00%
0/10 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
4.2%
5/119 • Number of events 5 • Adverse Events were assessed 7 days from the time of each vaccination in Years 1 and 2
|
Additional Information
Patrick E. Duffy
Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health
Phone: 301.761.5089
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Before either Party submits a paper or abstract for publication or otherwise intends to publicly disclose information about a CRADA Subject Invention, CRADA Data, or CRADA Materials, the other Party will have thirty (30) days to review proposed manuscripts and fifteen (15) days to review proposed abstracts to assure that Confidential Information is protected. Dr. Patrick Duffy is employed by the clinical sponsor, NIAID (clinical sponsor). Dr. Sagara is not employed by either sponsor.
- Publication restrictions are in place
Restriction type: OTHER