Last updated: 10/08/2020 13:30:06
Study of Safety, Immunogenicity and Efficacy of a candidate Malaria Vaccine in Tanzanian Infants
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Phase IIb randomized, double-blind, controlled study of the safety, immunogenicity and proof-of-concept of RTS,S/AS02D, a candidate malaria vaccine, when incorporated into an Expanded Program on Immunization (EPI) regimen that includes DTPw/Hib in infants living in a malaria-endemic region.
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Concentrations of antibodies against hepatitis B (Anti-HB)
Timeframe: Prior to vaccination at Week 0 (PRE), at Month 2 and at Month 3.
Number of subjects with serious adverse events (SAEs)
Timeframe: From Week 0 to Month 9.
Concentrations of antibodies against diphtheria (Anti-D)
Timeframe: Prior to vaccination at Week 0 (PRE), and at Month 3.
Concentrations of antibodies against tetanus (Anti-T)
Timeframe: Prior to vaccination at Week 0 (PRE), and at Month 3.
Concentrations of anti-polyribosyl ribitol phosphate antibodies (Anti-PRP).
Timeframe: Prior to vaccination at Week 0 (PRE), and at Month 3.
Number of subjects with serious adverse events (SAEs)
Timeframe: From Month 9 to Month 20.
Concentrations of anti-Bordetella pertussis toxin antibodies (Anti-BPT).
Timeframe: Prior to vaccination at Week 0 (PRE), and at Month 3.
Number of subjects with hepatitis B antibody (Anti-HB) concentrations equal to or above (>=) the seroprotection cut-off value
Timeframe: Prior to vaccination at Week 0 (PRE), at Month 2 and at Month 3.
Number of subjects with anti-diphtheria antibody (Anti-D) concentrations equal to or above (>=) the seroprotection cut-off value
Timeframe: Prior to vaccination at Week 0 (PRE), and at Month 3.
Number of subjects with anti-tetanus antibody (Anti-T) concentrations equal to or above (>=) the seroprotection cut-off value
Timeframe: Prior to vaccination at Week 0 (PRE), and at Month 3.
Number of subjects with anti-polyribosyl ribitol phosphate antibody (Anti-PRP) concentrations equal to or above (>=) the seroprotection cut-off value
Timeframe: Prior to vaccination at Week 0 (PRE), and at Month 3.
Number of subjects with anti-Bordetella pertussis toxin antibody (Anti-BPT) concentrations equal to or above (>=) the seropositivity cut-off value
Timeframe: Prior to vaccination at Week 0 (PRE), and at Month 3.
Secondary outcomes:
Concentrations of anti-Circumsporozoite protein (Anti-CS) antibodies
Timeframe: Prior to vaccination at Week 0 (PRE), at Month 2, at Month 3 and at Month 9.
Number of subjects with solicited local symptoms.
Timeframe: Within 7 days (Days 0-6) after vaccination with the RTS,S/AS02D or Engerix-B vaccine.
Number of subjects with solicited local symptoms.
Timeframe: Within 7 days (Days 0-6) after vaccination with the TETRActHib vaccine.
Number of subjects with solicited general symptoms.
Timeframe: Within 7 days (Days 0-6) after vaccination
Number of subjects with unsolicited adverse events (AEs).
Timeframe: Within 30 days (Days 0–29) after vaccination
Number of subjects with serious adverse events (SAEs)
Timeframe: Throughout the entire study, from Week 0 to Month 20.
Time to first malaria infection
Timeframe: Over the period starting 14 days after Dose 3 of RTS,S or HBV vaccine and extending for 6 months thereafter (from Month 2.5 up to Month 9).
Number of subjects prevalent for parasitemia
Timeframe: At Month 9
Plasmodium falciparum (P. falciparum) parasite density in subjects prevalent for parasitemia
Timeframe: At Month 9
Interventions:
Biological/vaccine: RTS,S/AS02D
Biological/vaccine: Engerix-B®
Biological/vaccine: TETRActHib™
Enrollment:
340
Observational study model:
Not applicable
Primary completion date:
2008-11-02
Time perspective:
Not applicable
Clinical publications:
Abdulla S et al. (2008) Safety and immunogenicity of RTS,S/AS02D malaria vaccine in infants. N Engl J Med. 359(24):2533-2544.
Medical condition
Malaria
Product
SB257049
Collaborators
Not applicable
Study date(s)
September 2006 to January 2009
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
6 - 10 weeks
Accepts healthy volunteers
Yes
- 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.
- Acute disease at the time of enrolment.
- Serious acute or chronic illness determined by clinical or physical examination and laboratory screening tests.
Inclusion and exclusion 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.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2008-11-02
Actual study completion date
2009-15-01
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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