Phase 2
N=340
Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine in Tanzanian Infants
Malaria · Malaria Vaccines
Bottom Line
View on ClinicalTrials.gov: NCT00289185 ↗Enrolled (actual)
340
Serious AEs
35.0%
Results posted
Jul 2013
Primary outcome: Primary: Concentrations of Antibodies Against Hepatitis B (Anti-HB) — 13.0; 14.3; 16.9; 111.8 milli-international unit per milliliter
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- RTS,S/AS02D (Biological); Engerix-B® (Biological); TETRActHib™ (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Concentrations of Antibodies Against Hepatitis B (Anti-HB) |
13.0; 14.3; 16.9; 111.8; 113.8; 667.4 | — |
| PRIMARY Number of Subjects With Serious Adverse Events (SAEs) |
62; 57 | — |
| PRIMARY Concentrations of Antibodies Against Diphtheria (Anti-D) |
NA; NA; 1.3; 1.1 | — |
| PRIMARY Concentrations of Antibodies Against Tetanus (Anti-T) |
1.1; 1.2; 4.2; 3.0 | — |
| PRIMARY Concentrations of Anti-polyribosyl Ribitol Phosphate Antibodies (Anti-PRP). |
0.2; 0.2; 19.3; 14.3 | — |
| PRIMARY Number of Subjects With Serious Adverse Events (SAEs) |
62; 57 | — |
| PRIMARY Concentrations of Anti-Bordetella Pertussis Toxin Antibodies (Anti-BPT). |
7.6; 7.6; 101.4; 82.3 | — |
| PRIMARY Number of Subjects With Hepatitis B Antibody (Anti-HB) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value |
45; 44; 82; 141; 133; 141 | — |
| PRIMARY Number of Subjects With Anti-diphtheria Antibody (Anti-D) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value |
27; 24; 148; 148 | — |
| PRIMARY Number of Subjects With Anti-tetanus Antibody (Anti-T) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value |
156; 155; 151; 149 | — |
| PRIMARY Number of Subjects With Anti-polyribosyl Ribitol Phosphate Antibody (Anti-PRP) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value |
86; 78; 150; 147 | — |
| PRIMARY Number of Subjects With Anti-Bordetella Pertussis Toxin Antibody (Anti-BPT) Concentrations Equal to or Above (>=) the Seropositivity Cut-off Value |
2; 1; 142; 148 | — |
| SECONDARY Concentrations of Anti-Circumsporozoite Protein (Anti-CS) Antibodies |
NA; NA; NA; 28.9; NA; 69.5 | — |
| SECONDARY Number of Subjects With Solicited Local Symptoms. |
169; 168; 68; 67 | — |
| SECONDARY Number of Subjects With Solicited Local Symptoms. |
169; 168; 68; 67 | — |
| SECONDARY Number of Subjects With Solicited General Symptoms. |
4; 3; 52; 103; 71; 81 | — |
| SECONDARY Number of Subjects With Unsolicited Adverse Events (AEs). |
141; 137 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
62; 57 | — |
| SECONDARY Time to First Malaria Infection |
0.29; 0.12 | — |
| SECONDARY Number of Subjects Prevalent for Parasitemia |
1; 0 | — |
| SECONDARY Plasmodium Falciparum (P. Falciparum) Parasite Density in Subjects Prevalent for Parasitemia |
23276 | — |
Summary
GSK Biologicals in partnership with the Malaria Vaccine Initiative at PATH is developing a candidate malaria vaccine GSK 257049 for the routine immunization of infants and children living in malaria endemic areas. The vaccine would offer protection against malaria disease due to the parasite Plasmodium falciparum. The vaccine would also provide protection against infection with hepatitis B virus (HBV).
In order to integrate the malaria vaccine into the EPI regimen in malaria-endemic regions, a new variant RTS,S/AS02D (0.5 mL dose) has been developed.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Eligibility Criteria
Inclusion criteria
- A male or female infant between 6 and 10 weeks of age at the time of first vaccination.
- Written or oral, signed or thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child.
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. return for follow-up visits).
- Born to a mother who is HBsAg negative & HIV negative.
- Born after a normal gestation period (between 36 and 42 weeks).
- Subjects who live within a 5 km radius of a dispensary.
Exclusion criteria
- Acute disease at the time of enrolment.
- Serious acute or chronic illness determined by clinical or physical examination and laboratory screening tests.
- Laboratory screening tests out of range for haemoglobin, total white cell count, platelets, ALT and creatinine.
- Previous vaccination with diphtheria, tetanus, pertussis (whole-cell or acellular), Hemophilus influenzae type b or hepatitis B vaccines.
- BCG administration within one week of proposed administration of a study vaccine.
- Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s).
- Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Administration of immunoglobulins, blood transfusions or other blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Previous participation in any other malaria vaccine trial.
- Simultaneous participation in any other clinical trial.
- Same sex twin.
- Maternal death.
- History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.
Data sourced from ClinicalTrials.gov (NCT00289185). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.