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Safety, Immunogenicity of RTS,S/AS02A, and RTS,S/AS01B Malaria Vaccines in Malaria-experienced Adults.

Primary Purpose

Plasmodium Falciparum

Status
Completed
Phase
Phase 2
Locations
Kenya
Study Type
Interventional
Intervention
RTS, S/AS01B
RTS, S/AS02A
Rabipur (Rabies) Vaccine
Sponsored by
U.S. Army Medical Research and Development Command
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Plasmodium Falciparum

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria: Healthy male or female volunteers aged between 18 and 35 years at the time of first vaccination who have given written consent for their participation in the study were included If the volunteer is female, she must be of non-childbearing potential, i.e. either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series Exclusion criteria: If a subject plans to take vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid will be excluded Volunteers with any confirmed or suspected immunosuppressive or immunodeficient conditions Family history of congenital or hereditary immunodeficiency History of allergic reactions to previous immunizations HBsAg positive subjects History of splenectomy Pregnant or lactating females will be excluded from the study

Sites / Locations

  • U.S. Army Research Unit-Kenya

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

VACC 1 (RTS, S/AS01B)

VACC 2 (RTS, S/AS02A)

Rabipur (Rabies) Vaccine

Arm Description

RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.

RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.

Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.

Outcomes

Primary Outcome Measures

Safety: Proportion of Subjects With Grade 3 Solicited and Unsolicited General Reactions After Vaccination of RTS, S/AS02A and RTS, S/AS01B
Proportion of subjects with grade 3 solicited and unsolicited general reactions after vaccination of RTS, S/AS02A and RTS, S/AS01B during a 7 day follow-up period (day of vaccination + 6 days).
Safety: Number of Administered Doses Eliciting Grade 3 Unsolicited Symptoms
Grade 3 unsolicited symptoms reported following any number of administered doses
Safety: Number of Doses Eliciting Solicited Local Symptoms Reported Over 7 Day Follow-up Period
Incidence overall solicited general and local reactions over 7 day follow-up period after dose 1, 2 and 3 (Total Cohort)

Secondary Outcome Measures

Safety: Occurrence of SAEs
Percentage of subjects experiencing SAEs classified by MedRA System Organ Class and Preferred Term (Month 6.5-12)
Safety: Occurrence of SAEs
Percentage of subjects reporting SAEs classified by MedDRA System Organ Class and Preferred Term (Month 0-12)
Occurrence of Hematology Parameters Below Normal Range
Occurrence of hematology parameters below normal range (Total Cohort)
Occurrence of Biochemistry Parameters Above Normal Ranges
Occurrence of parameters of biochemical monitoring above normal ranges (Total Cohort)

Full Information

First Posted
September 13, 2005
Last Updated
February 10, 2021
Sponsor
U.S. Army Medical Research and Development Command
Collaborators
GlaxoSmithKline, Walter Reed Army Institute of Research (WRAIR)
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1. Study Identification

Unique Protocol Identification Number
NCT00197054
Brief Title
Safety, Immunogenicity of RTS,S/AS02A, and RTS,S/AS01B Malaria Vaccines in Malaria-experienced Adults.
Official Title
A Phase IIb Randomized, Double-blind, Controlled Study of the Safety, Immunogenicity and Proof-of-concept of RTS,S/AS02A, and RTS,S/AS01B, Two Candidate Malaria Vaccines in Malaria-experienced Adults Living in Western Kenya.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
July 2005 (Actual)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
U.S. Army Medical Research and Development Command
Collaborators
GlaxoSmithKline, Walter Reed Army Institute of Research (WRAIR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The candidate malaria vaccine RTS,S/AS02A developed by GSK Biologicals demonstrated 30% efficacy against clinical episodes of malaria and approximately 58% efficacy against severe malaria disease. As a potential improvement to RTS,S/AS02A, another candidate vaccine RTS,S/AS01B is being developed in parallel in collaboration with the Walter Reed Army Institute of Research (WRAIR). This study will be the first administration of the RTS,S/AS01B vaccine to the African adults to establish safety and immunogenicity in this population. Preliminary indication of vaccine efficacy with this adjuvant will be established by monitoring the time to the first infection with Plasmodium falciparum.
Detailed Description
The study comprises of 3 groups and the participating subjects will be randomly allocated to one of the three groups. The first group will receive RTS,S/AS01B, the second group will receive RTS,S/AS02A and the third group will receive rabies vaccine. Immunization will be given by IM injection on 0, 1, 2 month schedule. Infants will be followed up daily for 7 days for solicited symptoms and 30 days for unsolicited symptoms after each vaccine dose. Serious adverse events will be recorded throughout the study period. A week prior to Dose 3, subjects will be treated with a licenced anti-malarial drug. Starting from two weeks after Dose 3, the subjects will be monitored for a 14-week duration for detection of malaria infection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plasmodium Falciparum

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
255 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VACC 1 (RTS, S/AS01B)
Arm Type
Experimental
Arm Description
RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.
Arm Title
VACC 2 (RTS, S/AS02A)
Arm Type
Experimental
Arm Description
RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.
Arm Title
Rabipur (Rabies) Vaccine
Arm Type
Active Comparator
Arm Description
Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.
Intervention Type
Biological
Intervention Name(s)
RTS, S/AS01B
Intervention Description
0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.
Intervention Type
Biological
Intervention Name(s)
RTS, S/AS02A
Intervention Description
0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.
Intervention Type
Biological
Intervention Name(s)
Rabipur (Rabies) Vaccine
Intervention Description
1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Primary Outcome Measure Information:
Title
Safety: Proportion of Subjects With Grade 3 Solicited and Unsolicited General Reactions After Vaccination of RTS, S/AS02A and RTS, S/AS01B
Description
Proportion of subjects with grade 3 solicited and unsolicited general reactions after vaccination of RTS, S/AS02A and RTS, S/AS01B during a 7 day follow-up period (day of vaccination + 6 days).
Time Frame
7 day follow-up (day of vaccination + 6 days)
Title
Safety: Number of Administered Doses Eliciting Grade 3 Unsolicited Symptoms
Description
Grade 3 unsolicited symptoms reported following any number of administered doses
Time Frame
6.5 months
Title
Safety: Number of Doses Eliciting Solicited Local Symptoms Reported Over 7 Day Follow-up Period
Description
Incidence overall solicited general and local reactions over 7 day follow-up period after dose 1, 2 and 3 (Total Cohort)
Time Frame
7 day follow-up period (day of vaccination + 6 days)
Secondary Outcome Measure Information:
Title
Safety: Occurrence of SAEs
Description
Percentage of subjects experiencing SAEs classified by MedRA System Organ Class and Preferred Term (Month 6.5-12)
Time Frame
months 6.5 thru 12
Title
Safety: Occurrence of SAEs
Description
Percentage of subjects reporting SAEs classified by MedDRA System Organ Class and Preferred Term (Month 0-12)
Time Frame
months 0 thru 12
Title
Occurrence of Hematology Parameters Below Normal Range
Description
Occurrence of hematology parameters below normal range (Total Cohort)
Time Frame
Days 0, 6, 66, and 90; Months 6 and 12
Title
Occurrence of Biochemistry Parameters Above Normal Ranges
Description
Occurrence of parameters of biochemical monitoring above normal ranges (Total Cohort)
Time Frame
Days 0, 6, and 90
Other Pre-specified Outcome Measures:
Title
Seropositivity Rates for Anti-HBs Antibodies by Infection Status PRE
Description
Seropositivity rates and GMTs for Anti-HBs antibodies by infection status (Total Cohort) Seropositive >3.3 mlU/mL; Seroprotected >10 mIU/mL Infection defined as P. falciparum asexual parasitemia >0 PRE= Prevaccination
Time Frame
Prevaccination
Title
Seropositivity Rates for Anti-HBs Antibodies by Infection Status PIII(D90)
Description
Seropositivity rates and GMTs for Anti-HBs antibodies by infection status (Total Cohort) Seropositive >3.3 mlU/mL; Seroprotected: >10 mlU/mL Infection defined as P. falciparum asexual parasitemia >0 PIII(D90)= post dose 3 (day 90)
Time Frame
Day 90
Title
Seropositivity Rates for Anti-HBs Antibodies by Infection Status PIII(M12)
Description
Seropositivity rates and GMTs for Anti-HBs antibodies by infection status (Total Cohort) Seropositive >3.3 mlU/mL; Seroprotected: >10 mlU/mL Infection defined as P. falciparum asexual parasitemia >0 PIII(M12)= post dose 3 (month 12)
Time Frame
Month 12
Title
Seropositivity Rates for Anti-HBs Antibodies by Vaccine Group PRE
Description
Seropositivity rates for Anti-HBs antibodies by vaccine group (ATP Cohort for Immunogenicity). Seropositive >3.3 mlU/ML PRE=Prevaccination
Time Frame
Prevaccination
Title
Seropositivity Rates for Anti-HBs Antibodies by Vaccine Group PIII(D90)
Description
Seropositivity rates for Anti-HBs antibodies by vaccine group (ATP Cohort for Immunogenicity). Seropositive >3.3 mlU/ML PIII(D90)= post dose 3 (Day 90)
Time Frame
Day 90
Title
Seropositivity Rates for Anti-HBs Antibodies by Vaccine Group PIII(M12)
Description
Seropositivity rates for Anti-HBs antibodies by vaccine group (ATP Cohort for Immunogenicity). Seropositive >3.3 mlU/ML PIII(M12)= post dose 3 (Month 12)
Time Frame
Month 12
Title
Seroprotection Rates for Anti-HBs Antibodies by Vaccine Group PRE
Description
Seroprotection rates for Anti-HBs antibodies by vaccine group (ATP Cohort for Immunogenicity). Seroprotected >10 mlU/mL PRE=Prevaccination
Time Frame
Prevaccination
Title
Seroprotection Rates for Anti-HBs Antibodies by Vaccine Group PIII (D90)
Description
Seroprotection rates for Anti-HBs antibodies by vaccine group (ATP Cohort for Immunogenicity). Seroprotected >10 mlU/mL PIII(D90)= post dose 3 (Day 90)
Time Frame
Day 90
Title
Seroprotection Rates for Anti-HBs Antibodies by Vaccine Group PIII (M12)
Description
Seroprotection rates for Anti-HBs antibodies by vaccine group (ATP Cohort for Immunogenicity). Seroprotected >10 mlU/mL PIII(M12)= post dose 3 (Month 12)
Time Frame
Month 12
Title
Geometric Mean Antibody Titers (GMTs) for Anti-HBs Antibodies by Vaccine Group PRE
Description
Geometric mean antibody titers (GMTs) for Anti-HBs antibodies by vaccine group (According to protocol (ATP) Cohort for Immunogenicity) PRE=Prevaccination
Time Frame
Prevaccination
Title
Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Vaccine Group PIII (D90)
Description
Geometric mean titers (GMTs) for Anti-HBs antibodies by vaccine group (According to protocol (ATP) Cohort for Immunogenicity) PIII(D90)= post dose 3 (Day 90)
Time Frame
Day 90
Title
Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Vaccine Group PIII (M12)
Description
Geometric mean titers (GMTs) for Anti-HBs antibodies by vaccine group (According to protocol (ATP) Cohort for Immunogenicity) PIII(M12)= post dose 3 (Month 12)
Time Frame
Month 12
Title
Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Infection Status PRE
Description
Geometric mean titers (GMTs) for Anti-HBs antibodies by infection status (Total Cohort) Infection defined as P. falciparum asexual parasitemia >0 PRE= Prevaccination
Time Frame
Prevaccination
Title
Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Infection Status PIII (D90)
Description
Geometric mean titers (GMTs) for Anti-HBs antibodies by infection status (Total Cohort) Infection defined as P. falciparum asexual parasitemia >0 PIII(D90)= post dose 3 (day 90)
Time Frame
Day 90
Title
Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Infection Status PIII (M12)
Description
Geometric mean titers (GMTs) for Anti-HBs antibodies by infection status (Total Cohort) Infection defined as P. falciparum asexual parasitemia >0 PIII(M12)= post dose 3 (month 12)
Time Frame
Month 12
Title
Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PRE
Description
Geometric mean titers (GMTs) for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PRE= prevaccination
Time Frame
Prevaccination
Title
Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PII (D60)
Description
Geometric mean titers (GMTs) for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PII(D60)= post dose 2 (day 60)
Time Frame
1 month post dose 2
Title
Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PIII (D90)
Description
Geometric mean titers (GMTs) for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PIII(D90)= post dose 3 (day 90)
Time Frame
1 month post dose 3
Title
Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PIII (M6.5)
Description
Geometric mean titers (GMTs) for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PIII(M6.5)= post dose 3 (month 6.5)
Time Frame
4 months post dose 3
Title
Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PIII (M12)
Description
Geometric mean titers (GMTs) for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PIII(M12)= post dose 3 (month 12)
Time Frame
10 months post dose 3
Title
Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PRE
Description
Geometric mean antibody titers (GMTs) for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Infection defined as P. falciparum asexual parasitemia >0 PRE= Pre-vaccination
Time Frame
PRE
Title
Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PII (D60)
Description
Geometric mean antibody titers (GMTs) for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Infection defined as P. falciparum asexual parasitemia >0 PII(D60)= post dose 2 (day 60)
Time Frame
post dose 2 (day 60)
Title
Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PIII (D90)
Description
Geometric mean antibody titers (GMTs) for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Infection defined as P. falciparum asexual parasitemia >0 PIII(D90)= post dose 3 (day 90)
Time Frame
post dose 3 (day 90)
Title
Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PIII (M6.5)
Description
Geometric mean antibody titers (GMTs) for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Infection defined as P. falciparum asexual parasitemia >0 PIII(M6.5)= post dose 3 (month 6.5)
Time Frame
post dose 3 (month 6.5)
Title
Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PRE
Description
Seropositivity rates for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PRE= prevaccination
Time Frame
Prevaccination
Title
Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PII (D60)
Description
Seropositivity rates for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3. PII(D60)= post dose 2 (day 60)
Time Frame
1 month post dose 2
Title
Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PIII (D90)
Description
Seropositivity rates for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PIII(D90)= post dose 3 (day 90)
Time Frame
1 month post dose 3
Title
Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PIII (M6.5)
Description
Seropositivity rates for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PIII(M6.5)= post dose 3 (month 6.5)
Time Frame
4 months post dose 3
Title
Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PIII (M12)
Description
Seropositivity rates for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PIII(M12)= post dose 3 (month 12)
Time Frame
10 months post dose 3
Title
Seropositivity Rates for Anti-CS Antibodies by Infection Status PRE
Description
Seropositivity rates for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Seropositive: >0.5EU/mL Infection defined as P. falciparum asexual parasitemia >0 PRE= Pre-vaccination
Time Frame
Prevaccination
Title
Seropositivity Rates for Anti-CS Antibodies by Infection Status PII (D60)
Description
Seropositivity rates for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Seropositive: >0.5EU/mL Infection defined as P. falciparum asexual parasitemia >0 PII(D60)= post dose 2 (day 60)
Time Frame
post dose 2 (day 60)
Title
Seropositivity Rates for Anti-CS Antibodies by Infection Status PIII (D90)
Description
Seropositivity rates for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Seropositive: >0.5EU/mL Infection defined as P. falciparum asexual parasitemia >0 PIII(D90)= post dose 3 (day 90)
Time Frame
post dose 3 (day 90)
Title
Seropositivity Rates for Anti-CS Antibodies by Infection Status PIII (M6.5)
Description
Seropositivity rates for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Seropositive: >0.5EU/mL Infection defined as P. falciparum asexual parasitemia >0 PIII(M6.5)= post dose 3 (month 6.5)
Time Frame
post dose 3 (month 6.5)
Title
Efficacy: Vaccine Efficacy Against P. Falciparum Infection
Description
Number of subjects with an episode of parasitemia (first recording of infection of asexual stage falciparum parasites >0 detected by active detection of infection (ADI) or passive case detection)
Time Frame
14 days after dose 3 and extending for 14 weeks
Title
Percentage of Participants With Positive and Negative Parasite Density
Description
Percentage of participants with positive and negative parasite density at month 6.5
Time Frame
at month 6.5
Title
Geometric Mean Antibody Titers (GMTs) of Asexual P. Falciparum Parasitemia
Description
Geometric Mean Antibody Titers (GMTs) of Asexual P. falciparum parasitemia at Month 6.5
Time Frame
Month 6.5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: Healthy male or female volunteers aged between 18 and 35 years at the time of first vaccination who have given written consent for their participation in the study were included If the volunteer is female, she must be of non-childbearing potential, i.e. either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series Exclusion criteria: If a subject plans to take vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid will be excluded Volunteers with any confirmed or suspected immunosuppressive or immunodeficient conditions Family history of congenital or hereditary immunodeficiency History of allergic reactions to previous immunizations HBsAg positive subjects History of splenectomy Pregnant or lactating females will be excluded from the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
U.S. Army Research Unit-Kenya
City
Kisumu
Country
Kenya

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
GSK and WRAIR
Citations:
PubMed Identifier
19649245
Citation
Polhemus ME, Remich SA, Ogutu BR, Waitumbi JN, Otieno L, Apollo S, Cummings JF, Kester KE, Ockenhouse CF, Stewart A, Ofori-Anyinam O, Ramboer I, Cahill CP, Lievens M, Dubois MC, Demoitie MA, Leach A, Cohen J, Ballou WR, Heppner DG Jr. Evaluation of RTS,S/AS02A and RTS,S/AS01B in adults in a high malaria transmission area. PLoS One. 2009 Jul 31;4(7):e6465. doi: 10.1371/journal.pone.0006465.
Results Reference
derived

Learn more about this trial

Safety, Immunogenicity of RTS,S/AS02A, and RTS,S/AS01B Malaria Vaccines in Malaria-experienced Adults.

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