Trial Outcomes & Findings for Safety, Immunogenicity and Efficacy Against of a Combined Malaria Vaccine in Healthy Malaria-naïve Adults (NCT NCT01366534)

NCT ID: NCT01366534

Last Updated: 2019-06-18

Results Overview

P. falciparum parasitemia was defined as a positive blood slide.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

67 participants

Primary outcome timeframe

28 days following sporozoite challenge (Day 105)

Results posted on

2019-06-18

Participant Flow

Participant milestones

Participant milestones
Measure	Ad35.CS.01 Group Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.	GSK257049 Group Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.	Control Group Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
Overall Study STARTED	28	27	12
Overall Study COMPLETED	26	25	12
Overall Study NOT COMPLETED	2	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Ad35.CS.01 Group Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.	GSK257049 Group Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
Overall Study Lost to Follow-up	1	0
Overall Study Migrated	1	1
Overall Study Declined challenged	0	1

Baseline Characteristics

Safety, Immunogenicity and Efficacy Against of a Combined Malaria Vaccine in Healthy Malaria-naïve Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ad35.CS.01 Group n=28 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.	GSK257049 Group n=27 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.	Control Group n=12 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.	Total n=67 Participants Total of all reporting groups
Age, Continuous	29.9 Years STANDARD_DEVIATION 7.03 • n=5 Participants	30.3 Years STANDARD_DEVIATION 7.83 • n=7 Participants	29.8 Years STANDARD_DEVIATION 6.86 • n=5 Participants	30.04 Years STANDARD_DEVIATION 7.23 • n=4 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	10 Participants n=7 Participants	6 Participants n=5 Participants	32 Participants n=4 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	17 Participants n=7 Participants	6 Participants n=5 Participants	35 Participants n=4 Participants
Race/Ethnicity, Customized Races · African heritage/African American	9 Participants n=5 Participants	16 Participants n=7 Participants	5 Participants n=5 Participants	30 Participants n=4 Participants
Race/Ethnicity, Customized Races · American Indian or Alaskan native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Races · Asian - Central/South Asian heritage	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized Races · White - Caucasian/European heritage	15 Participants n=5 Participants	9 Participants n=7 Participants	5 Participants n=5 Participants	29 Participants n=4 Participants
Race/Ethnicity, Customized Races · Mixed Origin	3 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants

PRIMARY outcome

Timeframe: 28 days following sporozoite challenge (Day 105)

Population: The analyses were performed on the According-to-Protocol (ATP) cohort for Efficacy, which included all evaluable subjects who did not use any medication or blood products forbidden by the protocol, who did not report any under lying medical condition influencing immune responses, for whom efficacy data were available.

P. falciparum parasitemia was defined as a positive blood slide.

Outcome measures

Outcome measures
Measure	Control Group n=12 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.	Ad35.CS.01 Group n=25 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.	GSK257049 Group n=21 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
Number of Subjects With Plasmodium Falciparum Parasitemia Following Sporozoite Challenge	12 Participants	14 Participants	10 Participants

PRIMARY outcome

Timeframe: Within the 7-day (Day 0 - Day 6) follow-up period post-vaccination

Population: The analyses were performed on the Intention-to-treat (ITT) cohort, which included all subjects with at least one vaccine administration documented, who had their symptoms sheet filled in.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, pain that prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

Outcome measures

Outcome measures
Measure	Control Group Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.	Ad35.CS.01 Group n=28 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.	GSK257049 Group n=27 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 1	—	25 Participants	25 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 1	—	0 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 1	—	7 Participants	4 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 1	—	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 1	—	6 Participants	6 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 1	—	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 2	—	26 Participants	20 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 2	—	1 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 2	—	8 Participants	7 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 2	—	1 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 2	—	6 Participants	3 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 2	—	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 3	—	20 Participants	15 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 3	—	1 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 3	—	11 Participants	8 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 3	—	0 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 3	—	10 Participants	6 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 3	—	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Across Doses	—	27 Participants	26 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Across Doses	—	2 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Across Doses	—	15 Participants	11 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Across Doses	—	1 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Across Doses	—	13 Participants	11 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Across Doses	—	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Within the 7-day (Day 0 - Day 6) follow-up period post-vaccination

Assessed solicited general symptoms were chills, fatigue, gastrointestinal symptoms, headache and temperature \[defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade.Grade 3 Chills = rigors \[uncontrollable shivering more than (\>) 15 seconds\]. Grade 3 Fatigue, Gastrointestinal symptoms and Headache = symptoms that prevented normal activity. Grade 3 fever = fever higher than (\>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	Control Group Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.	Ad35.CS.01 Group n=28 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.	GSK257049 Group n=27 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Chills, Dose 1	—	7 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Chills, Dose 1	—	7 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Chills, Dose 1	—	2 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 1	—	9 Participants	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 1	—	9 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 1	—	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal symptoms, Dose 1	—	3 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal symptoms, Dose 1	—	3 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal symptoms, Dose 1	—	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 1	—	12 Participants	10 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 1	—	11 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 1	—	0 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Dose 1	—	3 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Dose 1	—	2 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Dose 1	—	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Chills, Dose 2	—	6 Participants	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Chills, Dose 2	—	6 Participants	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Chills, Dose 2	—	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 2	—	9 Participants	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 2	—	8 Participants	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 2	—	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal symptoms, Dose 2	—	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal symptoms, Dose 2	—	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal symptoms, Dose 2	—	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 2	—	10 Participants	12 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 2	—	9 Participants	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 2	—	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Dose 2	—	1 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Dose 2	—	1 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Dose 2	—	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Chills, Dose 3	—	8 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Chills, Dose 3	—	8 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Chills, Dose 3	—	2 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 3	—	8 Participants	10 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 3	—	8 Participants	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 3	—	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal symptoms, Dose 3	—	3 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal symptoms, Dose 3	—	3 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal symptoms, Dose 3	—	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 3	—	14 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 3	—	14 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 3	—	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Dose 3	—	2 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Dose 3	—	2 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Dose 3	—	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Chills, Across doses	—	15 Participants	13 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Chills, Across doses	—	15 Participants	13 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Chills, Across doses	—	4 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Across doses	—	15 Participants	17 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Across doses	—	15 Participants	14 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Across doses	—	1 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal symptoms, Across doses	—	5 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal symptoms, Across doses	—	5 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal symptoms, Across doses	—	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Across doses	—	21 Participants	14 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Across doses	—	21 Participants	13 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Across doses	—	1 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Across doses	—	6 Participants	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Across doses	—	5 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Across doses	—	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Within the 30-day (Day 0 - Day 29) follow-up period post-vaccination

Population: The analyses were performed on the Intention-to-treat (ITT) cohort, which included all subjects with at least one vaccine administration documented.

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Outcome measures

Outcome measures
Measure	Control Group Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.	Ad35.CS.01 Group n=28 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.	GSK257049 Group n=27 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
Number of Subjects With Any Unsolicited Adverse Events (AEs)	—	23 Participants	21 Participants

PRIMARY outcome

Timeframe: Within the 30-day (Day 0 - Day 29) follow-up period post-challenge

Population: The analyses were performed on the Intention-to-treat (ITT) cohort, which included all subjects with at least one vaccine administration documented. All challenged infectivity controls were also included in this cohort and presented as a separate group.

Outcome measures

Outcome measures
Measure	Control Group n=12 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.	Ad35.CS.01 Group n=25 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.	GSK257049 Group n=21 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
Number of Subjects With Any Unsolicited Adverse Events (AEs)	12 Participants	22 Participants	18 Participants

PRIMARY outcome

Timeframe: Throughout the study period (Day 0 - Day 236)

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Outcome measures
Measure	Control Group n=12 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.	Ad35.CS.01 Group n=28 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.	GSK257049 Group n=27 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
Number of Subjects With Serious Adverse Events (SAEs)	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From day of challenge (Day 0) up to 159 days post-challenge

The onset of P. falciparum parasitemia was defined by a positive blood slide.

Outcome measures

Outcome measures
Measure	Control Group n=12 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.	Ad35.CS.01 Group n=14 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.	GSK257049 Group n=10 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
Number of Days Until the Onset of P. Falciparum Parasitemia Following Sporozoite Challenge	12 Days Standard Deviation 2	14 Days Standard Deviation 1	14 Days Standard Deviation 2

SECONDARY outcome

Timeframe: 28 days post-dose 1 (Day 28), 28 days post-dose 2 (Day 56), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236)

Population: The analyses were performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements, who did not report any underlying medical condition influencing immune responses and for whom immunogenicity data were available.

Titers are presented as geometric mean titers (GMTs) and are measured in titers. Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore GMTs for this group are presented as from Day 77.

Outcome measures

Outcome measures
Measure	Control Group n=12 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.	Ad35.CS.01 Group n=26 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.	GSK257049 Group n=27 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
Anti-circumsporozoite Protein (Anti-CS) Antibody Titers D28	—	0.9 Titers Interval 0.6 to 1.4	14.7 Titers Interval 8.7 to 24.9
Anti-circumsporozoite Protein (Anti-CS) Antibody Titers D56	—	14.3 Titers Interval 9.4 to 21.6	79.2 Titers Interval 51.0 to 122.9
Anti-circumsporozoite Protein (Anti-CS) Antibody Titers D77	0.3 Titers Interval 0.3 to 0.3	55.5 Titers Interval 40.2 to 76.6	115.9 Titers Interval 77.0 to 174.5
Anti-circumsporozoite Protein (Anti-CS) Antibody Titers D105	0.5 Titers Interval 0.2 to 1.5	50.0 Titers Interval 36.0 to 69.5	96.6 Titers Interval 61.3 to 152.2
Anti-circumsporozoite Protein (Anti-CS) Antibody Titers D140	0.4 Titers Interval 0.2 to 0.8	40.5 Titers Interval 28.9 to 56.8	62.3 Titers Interval 42.5 to 91.2
Anti-circumsporozoite Protein (Anti-CS) Antibody Titers D236	0.3 Titers Interval 0.2 to 0.5	21.4 Titers Interval 15.3 to 30.1	29.2 Titers Interval 19.7 to 43.4

SECONDARY outcome

Outcome measures

Outcome measures
Measure	Control Group n=12 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.	Ad35.CS.01 Group n=26 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.	GSK257049 Group n=27 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
Anti-hepatitis B (Anti-HBs) Antibody Titers D28	—	53.0 Titers Interval 15.7 to 179.1	26596.6 Titers Interval 6100.1 to 115962.1
Anti-hepatitis B (Anti-HBs) Antibody Titers D56	—	15845.4 Titers Interval 3349.8 to 74953.1	59388.2 Titers Interval 21718.8 to 162392.0
Anti-hepatitis B (Anti-HBs) Antibody Titers D77	35.6 Titers Interval 5.3 to 240.6	30877.5 Titers Interval 11760.6 to 81068.5	103746.8 Titers Interval 46444.1 to 231749.9
Anti-hepatitis B (Anti-HBs) Antibody Titers D105	47.4 Titers Interval 7.3 to 308.9	28180.7 Titers Interval 12190.4 to 65145.8	77659.2 Titers Interval 35596.0 to 169427.8
Anti-hepatitis B (Anti-HBs) Antibody Titers D140	41.2 Titers Interval 6.4 to 265.8	29307.7 Titers Interval 14002.8 to 61340.8	47932.8 Titers Interval 22214.7 to 103424.7
Anti-hepatitis B (Anti-HBs) Antibody Titers D236	34.2 Titers Interval 6.3 to 187.1	15589.7 Titers Interval 7898.8 to 30768.9	40727.8 Titers Interval 18101.6 to 91636.2

SECONDARY outcome

Outcome measures

Outcome measures
Measure	Control Group n=12 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.	Ad35.CS.01 Group n=26 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.	GSK257049 Group n=27 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
Anti-Adenovirus Type 35 (Ad35) Neutralizing Antibody Titers at Specified Time Points D56	—	25.5 Titers Interval 16.6 to 39.1	16.5 Titers Interval 15.5 to 17.7
Anti-Adenovirus Type 35 (Ad35) Neutralizing Antibody Titers at Specified Time Points D28	—	27.3 Titers Interval 17.4 to 43.0	16.3 Titers Interval 15.7 to 17.0
Anti-Adenovirus Type 35 (Ad35) Neutralizing Antibody Titers at Specified Time Points D77	23.2 Titers Interval 13.3 to 40.7	26.3 Titers Interval 16.6 to 41.5	17.0 Titers Interval 15.6 to 18.6
Anti-Adenovirus Type 35 (Ad35) Neutralizing Antibody Titers at Specified Time Points D105	25.9 Titers Interval 13.4 to 50.0	22.1 Titers Interval 14.6 to 33.5	17.2 Titers Interval 15.3 to 19.4
Anti-Adenovirus Type 35 (Ad35) Neutralizing Antibody Titers at Specified Time Points D140	23.4 Titers Interval 14.2 to 38.7	20.8 Titers Interval 14.3 to 30.1	16.0 Titers Interval 16.0 to 16.0
Anti-Adenovirus Type 35 (Ad35) Neutralizing Antibody Titers at Specified Time Points D236	24.2 Titers Interval 14.1 to 41.5	21.3 Titers Interval 15.5 to 29.3	16.5 Titers Interval 15.5 to 17.5

SECONDARY outcome

Timeframe: 14 days post-dose 1 (Day 14), 14 days post-dose 2 (Day 42), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236)

CS-specific CD4+ T-cells expressing at least 2 cytokines/activation markers between IL-2, IFN-γ, TNF-α and CD40-L are presented here. Analysis was performed via intra-cellular staining (ICS) assays, data are presented as frequency of T-cells per million peripheral blood mononuclear cells (PBMCs).Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore the frequency for this group is presented as from Day 77.

Outcome measures

Outcome measures
Measure	Control Group n=11 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.	Ad35.CS.01 Group n=26 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.	GSK257049 Group n=24 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
Frequency of CS (Total CS or Repeat)-Specific CD4+ T-cells D14	—	143.23 T-cells/million PBMCs Standard Deviation 170.19	220.25 T-cells/million PBMCs Standard Deviation 188.34
Frequency of CS (Total CS or Repeat)-Specific CD4+ T-cells D42	—	1693.38 T-cells/million PBMCs Standard Deviation 1268.50	854.29 T-cells/million PBMCs Standard Deviation 911.56
Frequency of CS (Total CS or Repeat)-Specific CD4+ T-cells D77	96.00 T-cells/million PBMCs Standard Deviation 94.72	1364.95 T-cells/million PBMCs Standard Deviation 1025.92	608.59 T-cells/million PBMCs Standard Deviation 744.99
Frequency of CS (Total CS or Repeat)-Specific CD4+ T-cells D105	80.90 T-cells/million PBMCs Standard Deviation 88.40	1149.29 T-cells/million PBMCs Standard Deviation 560.47	622.27 T-cells/million PBMCs Standard Deviation 448.50
Frequency of CS (Total CS or Repeat)-Specific CD4+ T-cells D140	36.40 T-cells/million PBMCs Standard Deviation 75.39	893.68 T-cells/million PBMCs Standard Deviation 933.95	492.14 T-cells/million PBMCs Standard Deviation 424.34
Frequency of CS (Total CS or Repeat)-Specific CD4+ T-cells D236	59.55 T-cells/million PBMCs Standard Deviation 65.07	750.95 T-cells/million PBMCs Standard Deviation 676.98	363.69 T-cells/million PBMCs Standard Deviation 272.73

SECONDARY outcome

CS-specific CD8+ T-cells expressing at least 2 cytokines/activation markers between IL-2, IFN-γ, TNF-α and CD40-L are presented here. Analysis was performed via intra-cellular staining (ICS) assays, data are presented as frequency of T-cells per million peripheral blood mononuclear cells (PBMC). Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore the frequency for this group is presented as from Day 77.

Outcome measures

Outcome measures
Measure	Control Group n=11 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.	Ad35.CS.01 Group n=26 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.	GSK257049 Group n=24 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
Frequency of CS (Total CS or Repeat)-Specific CD8+ T Cells D14	—	37.04 T-cells/million PBMCs Standard Deviation 64.66	18.29 T-cells/million PBMCs Standard Deviation 33.10
Frequency of CS (Total CS or Repeat)-Specific CD8+ T Cells D42	—	76.81 T-cells/million PBMCs Standard Deviation 107.06	25.29 T-cells/million PBMCs Standard Deviation 37.31
Frequency of CS (Total CS or Repeat)-Specific CD8+ T Cells D77	19.00 T-cells/million PBMCs Standard Deviation 32.21	94.86 T-cells/million PBMCs Standard Deviation 153.45	31.35 T-cells/million PBMCs Standard Deviation 34.89
Frequency of CS (Total CS or Repeat)-Specific CD8+ T Cells D105	8.50 T-cells/million PBMCs Standard Deviation 16.43	131.47 T-cells/million PBMCs Standard Deviation 153.24	32.27 T-cells/million PBMCs Standard Deviation 40.73
Frequency of CS (Total CS or Repeat)-Specific CD8+ T Cells D140	44.60 T-cells/million PBMCs Standard Deviation 93.49	99.95 T-cells/million PBMCs Standard Deviation 159.19	26.18 T-cells/million PBMCs Standard Deviation 34.99
Frequency of CS (Total CS or Repeat)-Specific CD8+ T Cells D236	48.45 T-cells/million PBMCs Standard Deviation 68.98	42.74 T-cells/million PBMCs Standard Deviation 47.54	28.00 T-cells/million PBMCs Standard Deviation 51.66

SECONDARY outcome

HB-specific CD4+ T-cells expressing at least 2 cytokines/activation markers between IL-2, IFN-γ, TNF-α and CD40-L are presented here. Analysis was performed via intra-cellular staining (ICS) assays, data are presented as frequency of T-cells per million peripheral blood mononuclear cells (PBMCs). Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore the frequency for this group is presented as from Day 77.

Outcome measures

Outcome measures
Measure	Control Group n=11 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.	Ad35.CS.01 Group n=25 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.	GSK257049 Group n=25 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
Frequency of HBs-specific CD4+ T-cells D14	—	373.67 T-cells/million PBMCs Standard Deviation 613.02	1400.80 T-cells/million PBMCs Standard Deviation 2449.05
Frequency of HBs-specific CD4+ T-cells D42	—	1518.36 T-cells/million PBMCs Standard Deviation 1526.01	1836.33 T-cells/million PBMCs Standard Deviation 2264.88
Frequency of HBs-specific CD4+ T-cells D77	232.13 T-cells/million PBMCs Standard Deviation 301.75	1163.77 T-cells/million PBMCs Standard Deviation 1022.03	1023.58 T-cells/million PBMCs Standard Deviation 936.22
Frequency of HBs-specific CD4+ T-cells D105	569.70 T-cells/million PBMCs Standard Deviation 489.67	1265.00 T-cells/million PBMCs Standard Deviation 863.73	1310.53 T-cells/million PBMCs Standard Deviation 747.79
Frequency of HBs-specific CD4+ T-cells D140	531.90 T-cells/million PBMCs Standard Deviation 407.21	1158.47 T-cells/million PBMCs Standard Deviation 804.40	1181.00 T-cells/million PBMCs Standard Deviation 603.43
Frequency of HBs-specific CD4+ T-cells D236	498.36 T-cells/million PBMCs Standard Deviation 313.94	940.16 T-cells/million PBMCs Standard Deviation 564.66	1244.38 T-cells/million PBMCs Standard Deviation 833.86

SECONDARY outcome

The analysis was performed via Enzyme-Linked Immunospot (ELISPOT) full length assay. Data are presented as the number of spots per million peripheral blood mononuclear cells (PBMCs). Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore the frequency for this group is presented as from Day 77.

Outcome measures

Outcome measures
Measure	Control Group n=12 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.	Ad35.CS.01 Group n=26 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.	GSK257049 Group n=27 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
Frequency of CS-specific T-cells Producing IFN-γ D14	—	51.05 spots/million PBMCs Standard Deviation 61.89	63.20 spots/million PBMCs Standard Deviation 100.85
Frequency of CS-specific T-cells Producing IFN-γ D42	—	297.97 spots/million PBMCs Standard Deviation 243.24	54.27 spots/million PBMCs Standard Deviation 53.52
Frequency of CS-specific T-cells Producing IFN-γ D77	66.68 spots/million PBMCs Standard Deviation 124.31	225.98 spots/million PBMCs Standard Deviation 161.51	64.54 spots/million PBMCs Standard Deviation 87.40
Frequency of CS-specific T-cells Producing IFN-γ D105	90.75 spots/million PBMCs Standard Deviation 219.50	232.35 spots/million PBMCs Standard Deviation 175.77	58.04 spots/million PBMCs Standard Deviation 76.86
Frequency of CS-specific T-cells Producing IFN-γ D140	75.74 spots/million PBMCs Standard Deviation 135.72	208.97 spots/million PBMCs Standard Deviation 125.45	50.77 spots/million PBMCs Standard Deviation 71.69
Frequency of CS-specific T-cells Producing IFN-γ D236	105.12 spots/million PBMCs Standard Deviation 255.20	167.91 spots/million PBMCs Standard Deviation 153.79	38.85 spots/million PBMCs Standard Deviation 56.36

SECONDARY outcome

Timeframe: 14 days post-dose 1 (Day 14)

The analysis was performed via Enzyme-Linked Immunospot (ELISPOT) N-terminal assay. Data are presented as the number of spots per million peripheral blood mononuclear cells (PBMCs).

Outcome measures

Outcome measures
Measure	Control Group Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.	Ad35.CS.01 Group n=25 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.	GSK257049 Group n=27 Participants Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
Frequency of CS-specific T-cells Producing IFN-γ	—	18.88 spots/million PBMCs Standard Deviation 19.97	14.57 spots/million PBMCs Standard Deviation 18.39

Adverse Events

Ad35.CS.01 Group

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

GSK257049 Group

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	Ad35.CS.01 Group n=28 participants at risk Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.	GSK257049 Group n=27 participants at risk Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.	Control Group n=12 participants at risk Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
Gastrointestinal disorders Nausea (post-vaccination)	0.00% 0/28 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	7.4% 2/27 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	— 0/0 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).
General disorders Fatigue (post-vaccination)	53.6% 15/28 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	63.0% 17/27 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	— 0/0 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).
General disorders Malaise (post-vaccination)	7.1% 2/28 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	3.7% 1/27 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	— 0/0 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).
General disorders Pain (post-vaccination)	17.9% 5/28 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	7.4% 2/27 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	— 0/0 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).
Infections and infestations Nasopharyngitis (post-vaccination)	7.1% 2/28 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	18.5% 5/27 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	— 0/0 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).
Infections and infestations Upper respiratory tract infection (post-vaccination)	21.4% 6/28 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	18.5% 5/27 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	— 0/0 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).
Musculoskeletal and connective tissue disorders Arthralgia (post-vaccination)	3.6% 1/28 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	7.4% 2/27 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	— 0/0 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).
Musculoskeletal and connective tissue disorders Back pain (post-vaccination)	14.3% 4/28 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	3.7% 1/27 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	— 0/0 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).
Nervous system disorders Headache (post-vaccination)	10.7% 3/28 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	14.8% 4/27 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	— 0/0 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).
Reproductive system and breast disorders Dysmenorrhoea (post-vaccination)	10.7% 3/28 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	3.7% 1/27 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	— 0/0 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).
Respiratory, thoracic and mediastinal disorders Nasal congestion (post-vaccination)	3.6% 1/28 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	14.8% 4/27 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	— 0/0 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).
Respiratory, thoracic and mediastinal disorders Throat irritation	7.1% 2/28 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	0.00% 0/27 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	— 0/0 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).
Skin and subcutaneous tissue disorders Hyperhidrosis (post-vaccination)	0.00% 0/28 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	11.1% 3/27 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	— 0/0 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).
Skin and subcutaneous tissue disorders Pruritus (post-vaccination)	7.1% 2/28 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	7.4% 2/27 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	— 0/0 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).
Infections and infestations Malaria (post-challenge)	56.0% 14/25 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	47.6% 10/21 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	100.0% 12/12 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).
Nervous system disorders Headache (post-challenge)	20.0% 5/25 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	33.3% 7/21 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	16.7% 2/12 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain(post-challenge)	12.0% 3/25 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	0.00% 0/21 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	0.00% 0/12 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).
Gastrointestinal disorders Nausea (post-challenge)	4.0% 1/25 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	9.5% 2/21 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	0.00% 0/12 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).
Infections and infestations Upper respiratory tract infection (post-challenge)	4.0% 1/25 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	9.5% 2/21 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	16.7% 2/12 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).
Skin and subcutaneous tissue disorders Pruritus (post-challenge)	4.0% 1/25 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	9.5% 2/21 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	0.00% 0/12 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).
General disorders Pain- solicited local (post-vaccination)	96.4% 27/28 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	96.3% 26/27 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	— 0/0 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).
General disorders Redness (post-vaccination)	53.6% 15/28 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	40.7% 11/27 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	— 0/0 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).
General disorders Swelling (post-vaccination)	46.4% 13/28 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	40.7% 11/27 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	— 0/0 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).
General disorders Chills (post-vaccination)	53.6% 15/28 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	48.1% 13/27 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	— 0/0 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).
General disorders Gastrointestinal symptoms (post-vaccination)	17.9% 5/28 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	22.2% 6/27 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	— 0/0 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).
General disorders Headache- solicited general (post-vaccination)	75.0% 21/28 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	51.9% 14/27 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	— 0/0 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).
General disorders Temperature (post-vaccination)	21.4% 6/28 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	33.3% 9/27 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).	— 0/0 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).