Double-blind, Randomized, Controlled Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine
Condition: Malaria, Falciparum
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is currently evaluating one candidate malaria vaccine, FMP1/AS02A. This candidate
      malaria vaccine is being developed for the routine immunization of infants and children
      living in malaria-endemic areas. This vaccine would offer protection against malaria disease
      due to the parasite Plasmodium falciparum.

      Prior to the start of this study, FMP1/AS02A had been given to approximately 60 malaria-naïve
      adults and 40 adults and 90 children living in malaria-endemic regions.

      This study will investigate whether the candidate vaccine prevents malaria disease for 6
      months post-vaccination.

      One half of the enrolled subjects will receive FMP1/AS02A and the other half rabies vaccine
      (RabAvert).
    

Detailed description: 
      Field trial of a candidate antigen/adjuvant conducted at one study center with 12 outlying
      (satellite) field stations. Subjects were screened no more than 45 days prior to the first
      inoculation and were randomized on the first day of vaccination 1:1 between two arms
      (FMP1/AS02A and rabies vaccine). The planned immunization schedule was 0, 1, and 2 months for
      both study arms; however, the 4-week intervals between doses could be extended for up to 2
      additional weeks if temporary suspension was deemed advisable due to serious adverse events
      (SAEs) or other concerns. Vaccinations were administered intramuscularly (IM) in the left
      anterolateral thigh muscle unless a compelling reason for using an alternate injection site
      was evident. Each subject participated in the study approximately 14 months with 7-day
      follow-up for solicited adverse events (five visits: vaccination day plus post-vaccination
      days 1, 2, 3, and 6) and 30-day follow-up for unsolicited events (vaccination day plus 29
      subsequent days). Follow-up of SAEs continued for study duration. Active case detection
      occurred during the Efficacy Follow-up Period (169 days, starting 14 days after the third
      vaccination (Day 71)), active case detection commenced with visits approximately every 28
      days to the Walter Reed Project Kombewa clinic and terminated after 6 months (approximately
      Day 240). The primary study analysis for all endpoints was completed on the cleaned Efficacy
      Follow-up Period database after a data-lock-point. The Addendum Efficacy Follow-up Period
      (125 days) started with the end of the Efficacy Follow-up Period (approximately Day 240) and
      active case detection commenced with visits approximately every 28 days to the Walter Reed
      Project Kombewa Clinic and terminated after 10 months (approximately Day 364). The study
      addendum analysis for all endpoints was completed after the Addendum Efficacy Follow-up
      Period database after a data-lock-point.

      Malaria cases were detected actively and passively. Active case detection was handled through
      scheduled (1) facilitated participant visits to the Kombewa Clinic and (2) field worker
      visits to participant homes. Passive case detection was handled through unscheduled,
      self-presentation of participants to the Kombewa Clinic. At scheduled clinic visits, blood
      samples were taken from all subjects to determine parasite density and hemoglobin levels. At
      home visits, subjects with fever or other illness within the 24 hours were transported to the
      clinic for collection of blood samples.
    

Intervention name(s): FMP1/AS02A; RabAvert
Intervention type(s): Biological; Biological
Intervention description(s): FMP1/AS02A candidate malaria vaccine; RabAvert rabies vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects were screened no more than 45 days prior to the first inoculation and were randomized on the first day of vaccination 1:1 between two arms (FMP1/AS02A and rabies vaccine (RabAvert)).
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Plasmodium; falciparum; malaria; vaccine; AS02A adjuvant; FMP1; Merozoite surface protein-1