Trial Outcomes & Findings for NMRC-M3V-Ad-PfCA Vaccine - Clinical Trial 1 (NCT NCT00392015)

NCT ID: NCT00392015

Last Updated: 2021-05-21

Results Overview

To assess the safety and tolerability of NMRC-M3V-Ad-PfCA, in a dose-escalation design (Part A), in healthy malaria-naïve adults. Part A was a dose escalation of NMRC-M3V-AdPfCA (2 antigen combination) using two dose groups, 2x10\^10 pu (Group 1) and 1x10\^11 pu (Group 2). Subjects received a single intramuscular injection with the injections in the 2 groups staggered by 4 weeks in order to assess the safety and tolerability of the vaccine and define the dose to be used in Part B. The vaccine was to be considered safe and well-tolerated if there were no severe or serious adverse events related to vaccine administration.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 59 participants
• Primary outcome timeframe: Through Study Completion, an average of 1 year
• Results posted on: 2021-05-21

Participant Flow

Participant milestones

Measure	Group 1: NMRC-M3V-Ad-PfCA, 2x10^10 pu Part A is a dose escalation of NMRC-M3V-Ad-PfCA (2 antigen combination) using 2 dose groups: Group 1 received a single low dose of 2x10\^10 pu and Group 2 received a single high dose of 1x10\^11 pu. Injections were staggered by 4 weeks in order to assess the safety and tolerability of the vaccine and define the dose to be used in Part B.	Group 2: NMRC-M3V-Ad-PfCA, 1x10^11 pu Part A is a dose escalation of NMRC-M3V-Ad-PfCA (2 antigen combination) using 2 dose groups: Group 1 received a single low dose of 2x10\^10 pu and Group 2 received a single high dose of 1x10\^11 pu. Injections were staggered by 4 weeks in order to assess the safety and tolerability of the vaccine and define the dose to be used in Part B.	Group 3: NMRC-M3V-Ad-PfCA, 2x10^10 pu Part B is the challenge phase to assess protective efficacy. Subjects in part B received 2 intramuscular injections given 16 weeks apart: Group 3 NMRC-M3V-Ad-PfCA (2 antigen combination) at a dose of 2x10\^10 pu, or Group 4 NMRC-MV-Ad-PfC (single antigen) at 1x10\^10 pu dose. Infectivity control subjects were challenged with Group 3 and Group 4.	Group 3: Infectivity Control Infectivity control subjects were challenged with Group 3	Group 4: NMRC-MV-Ad-PfC, 1x10^10 pu Part B is the challenge phase to assess protective efficacy. Subjects in part B received 2 intramuscular injections given 16 weeks apart: Group 3 NMRC-M3V-Ad-PfCA (2 antigen combination) at a dose of 2x10\^10 pu, or Group 4 NMRC-MV-Ad-PfC (single antigen) at 1x10\^10 pu dose. Infectivity control subjects were challenged with Group 3 and Group 4.	Group 4: Infectivity Control Infectivity control subjects were challenged with Group 4
Overall Study STARTED	6	6	20	6	15	6
Overall Study COMPLETED	4	6	16	5	12	6
Overall Study NOT COMPLETED	2	0	4	1	3	0

Reasons for withdrawal

Measure	Group 1: NMRC-M3V-Ad-PfCA, 2x10^10 pu Part A is a dose escalation of NMRC-M3V-Ad-PfCA (2 antigen combination) using 2 dose groups: Group 1 received a single low dose of 2x10\^10 pu and Group 2 received a single high dose of 1x10\^11 pu. Injections were staggered by 4 weeks in order to assess the safety and tolerability of the vaccine and define the dose to be used in Part B.	Group 2: NMRC-M3V-Ad-PfCA, 1x10^11 pu Part A is a dose escalation of NMRC-M3V-Ad-PfCA (2 antigen combination) using 2 dose groups: Group 1 received a single low dose of 2x10\^10 pu and Group 2 received a single high dose of 1x10\^11 pu. Injections were staggered by 4 weeks in order to assess the safety and tolerability of the vaccine and define the dose to be used in Part B.	Group 3: NMRC-M3V-Ad-PfCA, 2x10^10 pu Part B is the challenge phase to assess protective efficacy. Subjects in part B received 2 intramuscular injections given 16 weeks apart: Group 3 NMRC-M3V-Ad-PfCA (2 antigen combination) at a dose of 2x10\^10 pu, or Group 4 NMRC-MV-Ad-PfC (single antigen) at 1x10\^10 pu dose. Infectivity control subjects were challenged with Group 3 and Group 4.	Group 3: Infectivity Control Infectivity control subjects were challenged with Group 3	Group 4: NMRC-MV-Ad-PfC, 1x10^10 pu Part B is the challenge phase to assess protective efficacy. Subjects in part B received 2 intramuscular injections given 16 weeks apart: Group 3 NMRC-M3V-Ad-PfCA (2 antigen combination) at a dose of 2x10\^10 pu, or Group 4 NMRC-MV-Ad-PfC (single antigen) at 1x10\^10 pu dose. Infectivity control subjects were challenged with Group 3 and Group 4.	Group 4: Infectivity Control Infectivity control subjects were challenged with Group 4
Overall Study Lost to Follow-up	2	0	2	1	1	0
Overall Study Withdrawal by Subject	0	0	2	0	0	0
Overall Study Adverse Event	0	0	0	0	1	0
Overall Study Previous trial recipient	0	0	0	0	1	0

Baseline Characteristics

NMRC-M3V-Ad-PfCA Vaccine - Clinical Trial 1

Baseline characteristics by cohort

Measure	Group 1: NMRC-M3V-Ad-PfCA, 2x10^10 pu n=6 Participants Part A is a dose escalation of NMRC-M3V-Ad-PfCA (2 antigen combination) using 2 dose groups: Group 1 received a single low dose of 2x10\^10 pu and Group 2 received a single high dose of 1x10\^11 pu. Injections were staggered by 4 weeks in order to assess the safety and tolerability of the vaccine and define the dose to be used in Part B.	Group 2: NMRC-M3V-Ad-PfCA,1x10^11 pu n=6 Participants Part A is a dose escalation of NMRC-M3V-Ad-PfCA (2 antigen combination) using 2 dose groups: Group 1 received a single low dose of 2x10\^10 pu and Group 2 received a single high dose of 1x10\^11 pu. Injections were staggered by 4 weeks in order to assess the safety and tolerability of the vaccine and define the dose to be used in Part B.	Group 3: NMRC-M3V-Ad-PfCA, 2x10^10 pu n=20 Participants Part B is the challenge phase to assess protective efficacy. Subjects in part B received 2 intramuscular injections given 16 weeks apart: Group 3 NMRC-M3V-Ad-PfCA (2 antigen combination) at a dose of 2x10\^10 pu, or Group 4 NMRC-MV-Ad-PfC (single antigen) at 1x10\^10 pu dose. Infectivity control subjects were challenged with Group 3 and Group 4.	Group 3: Infectivity Control n=6 Participants Infectivity control subjects were challenged with Group 3 and Group 4	Group 4: NMRC-MV-Ad-PfC, 1x10^10 pu n=15 Participants Part B is the challenge phase to assess protective efficacy. Subjects in part B received 2 intramuscular injections given 16 weeks apart: Group 3 NMRC-M3V-Ad-PfCA (2 antigen combination) at a dose of 2x10\^10 pu, or Group 4 NMRC-MV-Ad-PfC (single antigen) at 1x10\^10 pu dose. Infectivity control subjects were challenged with Group 3 and Group 4.	Group 4: Infectivity Control n=6 Participants Infectivity control subjects were challenged with Group 3 and Group 4	Total n=59 Participants Total of all reporting groups
Age, Customized 18-20 years	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	3 Participants n=8 Participants
Age, Customized 21-30 years	3 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants	2 Participants n=8 Participants	23 Participants n=8 Participants
Age, Customized 31-40 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	6 Participants n=21 Participants	1 Participants n=8 Participants	16 Participants n=8 Participants
Age, Customized 41-50 years	1 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants	3 Participants n=8 Participants	17 Participants n=8 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants	3 Participants n=8 Participants	20 Participants n=8 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	2 Participants n=7 Participants	14 Participants n=5 Participants	4 Participants n=4 Participants	11 Participants n=21 Participants	3 Participants n=8 Participants	39 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	6 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	6 Participants n=7 Participants	17 Participants n=5 Participants	5 Participants n=4 Participants	14 Participants n=21 Participants	6 Participants n=8 Participants	53 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	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
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=8 Participants	2 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	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
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants	3 Participants n=4 Participants	8 Participants n=21 Participants	1 Participants n=8 Participants	26 Participants n=8 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants	5 Participants n=8 Participants	24 Participants n=8 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	6 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	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
Region of Enrollment United States	6 participants n=5 Participants	6 participants n=7 Participants	20 participants n=5 Participants	6 participants n=4 Participants	15 participants n=21 Participants	6 participants n=8 Participants	59 participants n=8 Participants

PRIMARY outcome

Timeframe: Through Study Completion, an average of 1 year

To assess the safety and tolerability of NMRC-M3V-Ad-PfCA, in a dose-escalation design (Part A), in healthy malaria-naïve adults. Part A was a dose escalation of NMRC-M3V-AdPfCA (2 antigen combination) using two dose groups, 2x10^10 pu (Group 1) and 1x10^11 pu (Group 2). Subjects received a single intramuscular injection with the injections in the 2 groups staggered by 4 weeks in order to assess the safety and tolerability of the vaccine and define the dose to be used in Part B. The vaccine was to be considered safe and well-tolerated if there were no severe or serious adverse events related to vaccine administration.

Outcome measures

Measure	Group 1 n=6 Participants Group 1 received NMRC-M3V-Ad-PfCA (2 antigen combination) at a single low dose of 2x10\^10 pu on Week 0	Group 2 n=6 Participants Group 2 received NMRC-M3V-Ad-PfCA (2 antigen combination) at a single high dose of 1x10\^11 pu on Week 4.	Group 4 2 doses of NMRC-MV-Ad-PfC (1x10\^10 pu) administered intramuscular 16 weeks apart on Week 16 and Week 32 followed by a sporozoite challenge 3 weeks later. Infectivity control subjects (not vaccinated) were also challenged.	Group 4 Infectivity Control Infectivity control subjects (not vaccinated) were also challenged
Part A Dose-Escalation: Number of Participants Who Experienced Any Serious Adverse Events Related To Vaccine Administration	0 Participants	0 Participants	—	—

PRIMARY outcome

Timeframe: Through Study Completion, an average of 1 year

To assess the safety and tolerability of NMRC-M3V-Ad-PfCA, in a regimen-comparison design (Part B), in healthy malaria-naïve adults. Subjects in part B received 2 intramuscular injections given 16 weeks apart: Group 3 NMRC-M3V-Ad-PfCA (2 antigen combination) at a dose of 2x10^10 pu, or Group 4 NMRC-MV-Ad-PfC (single antigen) at 1x10^10 pu dose. The vaccine was to be considered safe and well-tolerated if there were no severe or serious adverse events related to vaccine administration.

Outcome measures

Measure	Group 1 n=20 Participants Group 1 received NMRC-M3V-Ad-PfCA (2 antigen combination) at a single low dose of 2x10\^10 pu on Week 0	Group 2 n=15 Participants Group 2 received NMRC-M3V-Ad-PfCA (2 antigen combination) at a single high dose of 1x10\^11 pu on Week 4.	Group 4 2 doses of NMRC-MV-Ad-PfC (1x10\^10 pu) administered intramuscular 16 weeks apart on Week 16 and Week 32 followed by a sporozoite challenge 3 weeks later. Infectivity control subjects (not vaccinated) were also challenged.	Group 4 Infectivity Control Infectivity control subjects (not vaccinated) were also challenged
Part B Regimen-Comparison: Number of Participants With Any Serious Adverse Events Related to Vaccine Administration	0 Participants	0 Participants	—	—

PRIMARY outcome

Timeframe: Through Study Completion, an average of 1 year

Protective efficacy was assessed by conducting a homologous 3D7 strain sporozoite challenge 3 weeks after the second NMRCMV-Ad-PfC immunization. Time to parasitemia was measured in both vaccinated and unvaccinated volunteers (infectivity controls) in Group 3 (NMRC-M3V-Ad-PfCA (2 antigen combination) at a dose of 2x10^10 pu) and Group 4 (NMRC-MV-Ad-PfC (single antigen) at 1x10^10 pu dose). Infectivity control subjects were challenged with Group 3 and Group 4. Each volunteer was monitored for the onset of signs and symptoms of malaria and by daily Giemsa-stained thick blood films with positive films confirmed by a second reader. The identity of immunized and non-immunized volunteers was known to the clinical trial staff but not to the microscopists reading the malaria smears.

Outcome measures

Measure	Group 1 n=20 Participants Group 1 received NMRC-M3V-Ad-PfCA (2 antigen combination) at a single low dose of 2x10\^10 pu on Week 0	Group 2 n=6 Participants Group 2 received NMRC-M3V-Ad-PfCA (2 antigen combination) at a single high dose of 1x10\^11 pu on Week 4.	Group 4 n=15 Participants 2 doses of NMRC-MV-Ad-PfC (1x10\^10 pu) administered intramuscular 16 weeks apart on Week 16 and Week 32 followed by a sporozoite challenge 3 weeks later. Infectivity control subjects (not vaccinated) were also challenged.	Group 4 Infectivity Control n=6 Participants Infectivity control subjects (not vaccinated) were also challenged
Part B Regimen Comparison: Time to Parasitemia to Assess the Protective Efficacy Against Sporozoite Challenge (Pf, 3D7 Strain)	12.1 days Interval 9.0 to 16.0	11.8 days Interval 11.0 to 13.0	13.37 days Interval 12.0 to 16.0	12.96 days Interval 12.0 to 14.0

SECONDARY outcome

Timeframe: One month post immunization

The NMRC-M3V-Ad-PfCA vaccine combines two adenovectors encoding circumsporozoite protein (CSP) and apical membrane antigen-1 (AMA1). In Group 1 healthy volunteers received one intramuscular injection of 2x10^10 pu at Week 0 and in Group 2 a five-fold higher dose of 1 x 10^11 pu at Week 4. Immunogenicity was assessed by ELISpot IFN-γ responses against synthetic peptides derived from CSP and AMA1 as the range of spot forming cells/million peripheral blood mononuclear cells [sfc/m].

Outcome measures

Measure	Group 1 n=6 Participants Group 1 received NMRC-M3V-Ad-PfCA (2 antigen combination) at a single low dose of 2x10\^10 pu on Week 0	Group 2 n=6 Participants Group 2 received NMRC-M3V-Ad-PfCA (2 antigen combination) at a single high dose of 1x10\^11 pu on Week 4.	Group 4 2 doses of NMRC-MV-Ad-PfC (1x10\^10 pu) administered intramuscular 16 weeks apart on Week 16 and Week 32 followed by a sporozoite challenge 3 weeks later. Infectivity control subjects (not vaccinated) were also challenged.	Group 4 Infectivity Control Infectivity control subjects (not vaccinated) were also challenged
Part A Dose-Escalation: To Assess the Immunogenicity of NMRC-M3V-Ad-PfCA in Healthy Malaria-Naïve Adults Using ELISpot IFN-γ Responses Group 1	422 sfc/m Interval 422.0 to 337.0	862 sfc/m Interval 862.0 to 697.0	—	—
Part A Dose-Escalation: To Assess the Immunogenicity of NMRC-M3V-Ad-PfCA in Healthy Malaria-Naïve Adults Using ELISpot IFN-γ Responses Group 2	154 sfc/m Interval 154.0 to 203.0	423 sfc/m Interval 423.0 to 466.0	—	—

SECONDARY outcome

Timeframe: 22-23 days post immunization

The NMRC-M3V-Ad-PfCA vaccine combines two adenovectors encoding circumsporozoite protein (CSP) and apical membrane antigen-1 (AMA1). Group 3 healthy volunteers received 2 intramuscular injections of NMRC-M3V-Ad-PfCA (2 antigen combination) at a dose of 2x10^10 pu at Week 16 and Week 32. Immunogenicity was assessed by ELISpot IFN-γ responses against synthetic peptides derived from CSP and AMA1 using peripheral blood mononuclear cells during the study. IFN-γ ELISpot responses were measured as the range of spot forming cells/million peripheral blood mononuclear cells [sfc/m].

Outcome measures

Measure	Group 1 n=20 Participants Group 1 received NMRC-M3V-Ad-PfCA (2 antigen combination) at a single low dose of 2x10\^10 pu on Week 0	Group 2 n=20 Participants Group 2 received NMRC-M3V-Ad-PfCA (2 antigen combination) at a single high dose of 1x10\^11 pu on Week 4.	Group 4 2 doses of NMRC-MV-Ad-PfC (1x10\^10 pu) administered intramuscular 16 weeks apart on Week 16 and Week 32 followed by a sporozoite challenge 3 weeks later. Infectivity control subjects (not vaccinated) were also challenged.	Group 4 Infectivity Control Infectivity control subjects (not vaccinated) were also challenged
Part B Regimen-Comparison: To Assess the Immunogenicity of NMRC-M3V-Ad-PfCA in Healthy Malaria-Naïve Adults Using ELISpot IFN-γ Responses in Group 3	273 sfc/m Interval 38.0 to 2550.0	1303 sfc/m Interval 435.0 to 4594.0	—	—

SECONDARY outcome

Timeframe: 4 weeks post immunization

Group 4 healthy volunteers received 2 intramuscular injections of NMRC-MV-Ad-PfC (single antigen) at a dose of 1x10^10 pu at Week 16 and Week 32. Immunogenicity was assessed by ELISpot IFN-γ responses against synthetic peptides derived from circumsporozoite protein (CSP) using peripheral blood mononuclear cells during the study. IFN-γ ELISpot responses measured as the range of spot forming cells/million peripheral blood mononuclear cells [sfc/m].

Outcome measures

Measure	Group 1 n=15 Participants Group 1 received NMRC-M3V-Ad-PfCA (2 antigen combination) at a single low dose of 2x10\^10 pu on Week 0	Group 2 Group 2 received NMRC-M3V-Ad-PfCA (2 antigen combination) at a single high dose of 1x10\^11 pu on Week 4.	Group 4 2 doses of NMRC-MV-Ad-PfC (1x10\^10 pu) administered intramuscular 16 weeks apart on Week 16 and Week 32 followed by a sporozoite challenge 3 weeks later. Infectivity control subjects (not vaccinated) were also challenged.	Group 4 Infectivity Control Infectivity control subjects (not vaccinated) were also challenged
Part B Regimen-Comparison: To Assess the Immunogenicity of NMRC-MV-Ad-PfC in Healthy Malaria-Naïve Adults Using ELISpot IFN-γ Responses in Group 4	323 sfc/m Interval 71.0 to 1127.0	—	—	—

SECONDARY outcome

Timeframe: One month post immunization

The NMRC-M3V-Ad-PfCA vaccine combines two adenovectors encoding circumsporozoite protein (CSP) and apical membrane antigen-1 (AMA1). In Group 1 healthy volunteers received one intramuscular injection of 2x10^10 pu at Week 0 and in Group 2 a five-fold higher dose of 1 x 10^11 pu at Week 4. Immunogenicity was assessed by Intracellular Cytokine Staining of CD4+ and CD8+ T cell IFN-γ responses to AMA1 and CSP using peripheral blood mononuclear cells during the study. CD4+ and CD8+ T cell IFN-γ responses were measured as percentage (%) range of positive responses.

Outcome measures

Measure	Group 1 n=6 Participants Group 1 received NMRC-M3V-Ad-PfCA (2 antigen combination) at a single low dose of 2x10\^10 pu on Week 0	Group 2 n=6 Participants Group 2 received NMRC-M3V-Ad-PfCA (2 antigen combination) at a single high dose of 1x10\^11 pu on Week 4.	Group 4 2 doses of NMRC-MV-Ad-PfC (1x10\^10 pu) administered intramuscular 16 weeks apart on Week 16 and Week 32 followed by a sporozoite challenge 3 weeks later. Infectivity control subjects (not vaccinated) were also challenged.	Group 4 Infectivity Control Infectivity control subjects (not vaccinated) were also challenged
Part A Dose-Escalation: To Assess the Immunogenicity of NMRC-M3V-Ad-PfCA in Healthy Malaria-Naïve Adults Using Intracellular Cytokine Staining of CD4+ and CD8+ T Cell IFN-γ Responses Group 2 (% CD4+)	0.006 percentage of cells Interval 0.006 to 0.017	0.035 percentage of cells Interval 0.035 to 0.038	—	—
Part A Dose-Escalation: To Assess the Immunogenicity of NMRC-M3V-Ad-PfCA in Healthy Malaria-Naïve Adults Using Intracellular Cytokine Staining of CD4+ and CD8+ T Cell IFN-γ Responses Group 1 (% CD8+)	0.210 percentage of cells Interval 0.21 to 0.14	0.44 percentage of cells Interval 0.44 to 0.58	—	—
Part A Dose-Escalation: To Assess the Immunogenicity of NMRC-M3V-Ad-PfCA in Healthy Malaria-Naïve Adults Using Intracellular Cytokine Staining of CD4+ and CD8+ T Cell IFN-γ Responses Group 1 (% CD4+)	0.044 percentage of cells Interval 0.044 to 0.075	0.086 percentage of cells Interval 0.086 to 0.17	—	—
Part A Dose-Escalation: To Assess the Immunogenicity of NMRC-M3V-Ad-PfCA in Healthy Malaria-Naïve Adults Using Intracellular Cytokine Staining of CD4+ and CD8+ T Cell IFN-γ Responses Group 2 (% CD8+)	0.020 percentage of cells Interval 0.02 to 0.12	0.15 percentage of cells Interval 0.15 to 0.46	—	—

SECONDARY outcome

Timeframe: 22-23 days post immunization

The NMRC-M3V-Ad-PfCA vaccine combines two adenovectors encoding circumsporozoite protein (CSP) and apical membrane antigen-1 (AMA1). Group 3 healthy volunteers received 2 intramuscular injections of NMRC-M3V-Ad-PfCA (2 antigen combination) at a dose of 2x10^10 pu at Week 16 and Week 32. Immunogenicity was assessed by Intracellular Cytokine Staining of CD4+ and CD8+ T cell IFN-γ responses to AMA1 and CSP measured using peripheral blood mononuclear cells during the study. CD4+ and CD8+ T cell IFN-γ responses were measured as percentage (%) range of positive responses.

Outcome measures

Measure	Group 1 n=20 Participants Group 1 received NMRC-M3V-Ad-PfCA (2 antigen combination) at a single low dose of 2x10\^10 pu on Week 0	Group 2 n=20 Participants Group 2 received NMRC-M3V-Ad-PfCA (2 antigen combination) at a single high dose of 1x10\^11 pu on Week 4.	Group 4 2 doses of NMRC-MV-Ad-PfC (1x10\^10 pu) administered intramuscular 16 weeks apart on Week 16 and Week 32 followed by a sporozoite challenge 3 weeks later. Infectivity control subjects (not vaccinated) were also challenged.	Group 4 Infectivity Control Infectivity control subjects (not vaccinated) were also challenged
Part B Regimen-Comparison: To Assess the Immunogenicity of NMRC-M3V-Ad-PfCA in Healthy Malaria-Naïve Adults Using Intracellular Cytokine Staining CD4+ and CD8+ T Cell IFN-γ Responses in Group 3 % CD4+ Cells	0.030 percentage of cells Interval 0.02 to 0.18	0.090 percentage of cells Interval 0.027 to 0.478	—	—
Part B Regimen-Comparison: To Assess the Immunogenicity of NMRC-M3V-Ad-PfCA in Healthy Malaria-Naïve Adults Using Intracellular Cytokine Staining CD4+ and CD8+ T Cell IFN-γ Responses in Group 3 % CD8+ Cells	0.093 percentage of cells Interval 0.03 to 0.47	0.216 percentage of cells Interval 0.04 to 2.08	—	—

SECONDARY outcome

Timeframe: 4 weeks post immunization

Group 4 healthy volunteers received 2 intramuscular injections of NMRC-MV-Ad-PfC (single antigen) at a dose of 1x10^10 pu at Week 16 and Week 32. Immunogenicity was assessed by Intracellular Cytokine Staining of CD4+ and CD8+ T cell IFN-γ responses to synthetic peptides derived from circumsporozoite protein (CSP) using peripheral blood mononuclear cells during the study. CD4+ and CD8+ T cell IFN-γ responses were measured as percentage (%) range of positive responses.

Outcome measures

Measure	Group 1 n=15 Participants Group 1 received NMRC-M3V-Ad-PfCA (2 antigen combination) at a single low dose of 2x10\^10 pu on Week 0	Group 2 Group 2 received NMRC-M3V-Ad-PfCA (2 antigen combination) at a single high dose of 1x10\^11 pu on Week 4.	Group 4 2 doses of NMRC-MV-Ad-PfC (1x10\^10 pu) administered intramuscular 16 weeks apart on Week 16 and Week 32 followed by a sporozoite challenge 3 weeks later. Infectivity control subjects (not vaccinated) were also challenged.	Group 4 Infectivity Control Infectivity control subjects (not vaccinated) were also challenged
Part B Regimen-Comparison: To Assess the Immunogenicity of NMRC-MV-Ad-PfC in Healthy Malaria-Naïve Adults Using Intracellular Cytokine Staining of CD4+ and CD8+ T Cell IFN-γ Responses in Group 4 % CD4+ Cells	0.039 percentage of cells Interval 0.00141 to 0.137	—	—	—
Part B Regimen-Comparison: To Assess the Immunogenicity of NMRC-MV-Ad-PfC in Healthy Malaria-Naïve Adults Using Intracellular Cytokine Staining of CD4+ and CD8+ T Cell IFN-γ Responses in Group 4 % CD8+ Cells	0.09 percentage of cells Interval 0.012 to 0.556	—	—	—

Adverse Events

Group 1

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Group 2

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Group 3

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Group 3 Infectivity Control

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Group 4

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Group 4 Infectivity Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group 1 n=6 participants at risk Single low dose (2x10\^10 pu) of NMRC-M3V-Ad-PfCA administered intramuscular on Week 0	Group 2 n=6 participants at risk Single high dose (1x10\^11 pu) of NMRC-M3V-Ad-PfCA administered intramuscular on Week 4	Group 3 n=20 participants at risk 2 doses of NMRC-M3V-Ad-PfCA (2x10\^10 pu) administered intramuscular 16 weeks apart on Week 16 and Week 32 followed by a sporozoite challenge 2 to 4 weeks after the second immunization.	Group 3 Infectivity Control n=6 participants at risk Infectivity Control (not vaccinated) were also challenged	Group 4 n=15 participants at risk 2 doses of NMRC-MV-Ad-PfC (1x10\^10 pu) administered intramuscular 16 weeks apart on Week 16 and Week 32 followed by a sporozoite challenge 2 to 4 weeks after the second immunization.	Group 4 Infectivity Control n=6 participants at risk Infectivity Control (not vaccinated) were also challenged
Psychiatric disorders Depression	16.7% 1/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	0.00% 0/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	0.00% 0/20 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	0.00% 0/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	0.00% 0/15 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	0.00% 0/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.
Psychiatric disorders Suicide	0.00% 0/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	0.00% 0/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	0.00% 0/20 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	16.7% 1/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	0.00% 0/15 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	0.00% 0/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.

Other adverse events

Measure	Group 1 n=6 participants at risk Single low dose (2x10\^10 pu) of NMRC-M3V-Ad-PfCA administered intramuscular on Week 0	Group 2 n=6 participants at risk Single high dose (1x10\^11 pu) of NMRC-M3V-Ad-PfCA administered intramuscular on Week 4	Group 3 n=20 participants at risk 2 doses of NMRC-M3V-Ad-PfCA (2x10\^10 pu) administered intramuscular 16 weeks apart on Week 16 and Week 32 followed by a sporozoite challenge 2 to 4 weeks after the second immunization.	Group 3 Infectivity Control n=6 participants at risk Infectivity Control (not vaccinated) were also challenged	Group 4 n=15 participants at risk 2 doses of NMRC-MV-Ad-PfC (1x10\^10 pu) administered intramuscular 16 weeks apart on Week 16 and Week 32 followed by a sporozoite challenge 2 to 4 weeks after the second immunization.	Group 4 Infectivity Control n=6 participants at risk Infectivity Control (not vaccinated) were also challenged
General disorders Pain/tenderness	83.3% 5/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	83.3% 5/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	45.0% 9/20 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	86.7% 13/15 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.
General disorders Erythema	0.00% 0/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	0.00% 0/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	5.0% 1/20 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	0.00% 0/15 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.
General disorders Induration/swelling	0.00% 0/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	16.7% 1/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	5.0% 1/20 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	0.00% 0/15 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.
General disorders Warmth	0.00% 0/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	16.7% 1/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	10.0% 2/20 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	0.00% 0/15 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.
General disorders Hives	0.00% 0/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	0.00% 0/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	5.0% 1/20 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	0.00% 0/15 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.
General disorders Lymphadenopathy	33.3% 2/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	0.00% 0/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	0.00% 0/20 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	0.00% 0/15 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.
General disorders Limited arm motion	16.7% 1/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	0.00% 0/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	0.00% 0/20 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	0.00% 0/15 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.
Nervous system disorders Headache	33.3% 2/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	50.0% 3/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	15.0% 3/20 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	13.3% 2/15 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.
General disorders Malaise	16.7% 1/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	66.7% 4/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	15.0% 3/20 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	13.3% 2/15 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.
General disorders Fever	16.7% 1/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	66.7% 4/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	10.0% 2/20 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	6.7% 1/15 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.
General disorders Chills	0.00% 0/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	66.7% 4/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	10.0% 2/20 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	6.7% 1/15 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.
Musculoskeletal and connective tissue disorders Myalgia	33.3% 2/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	33.3% 2/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	15.0% 3/20 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	13.3% 2/15 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.
General disorders Fatigue	0.00% 0/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	0.00% 0/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	25.0% 5/20 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	13.3% 2/15 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.
Musculoskeletal and connective tissue disorders Arthralgia	16.7% 1/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	16.7% 1/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	5.0% 1/20 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	0.00% 0/15 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.
Gastrointestinal disorders Nausea/vomiting	33.3% 2/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	50.0% 3/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	10.0% 2/20 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	13.3% 2/15 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.
Gastrointestinal disorders Diarrhea	0.00% 0/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	16.7% 1/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	0.00% 0/20 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	13.3% 2/15 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.
Eye disorders Blurred vision	0.00% 0/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	16.7% 1/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	0.00% 0/20 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	0.00% 0/15 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.
Nervous system disorders Dizziness	0.00% 0/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	16.7% 1/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	5.0% 1/20 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	6.7% 1/15 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	0.00% 0/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	5.0% 1/20 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	0.00% 0/15 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.
Respiratory, thoracic and mediastinal disorders Pharyngitis	0.00% 0/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	0.00% 0/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	5.0% 1/20 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	6.7% 1/15 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.
Eye disorders Pink eye/conjunctivitis D	0.00% 0/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	0.00% 0/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	0.00% 0/20 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	6.7% 1/15 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	0.00% 0/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	0.00% 0/20 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	6.7% 1/15 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.
Eye disorders Eye pain/irritation	0.00% 0/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	0.00% 0/6 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	0.00% 0/20 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	6.7% 1/15 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.	— 0/0 • Through Study Completion, an average of 1 year Occurrence of solicited adverse events over a 14-day follow-up period (day of vaccination and 13 subsequent days) and unsolicited adverse events over a 30 day follow-up period (day of immunization and 29 subsequent days) in vaccinated subjects Groups 1-4. Other (Not Including Serious) Adverse Events were not collected for the infected control group. Serious adverse events during the one year active study period in vaccinated subjects Groups 1-4 and non-vaccinated infectivity control subjects.

Additional Information

Dr. Judith Epstein

United States Military Malaria Vaccine Program Naval Medical Research Center

Phone: 301-252-9026

Email: judith.epstein@med.navy.mil

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place