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AzTrials

Plasmodium FalciparumPhase 2NCT00197054

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

A Phase 2 study testing RTS, S/AS01B, RTS, S/AS02A and Rabipur (Rabies) Vaccine in people with Plasmodium Falciparum, run by U.S. Army Medical Research and Development Command at 1 site in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Plasmodium Falciparum
What is being tested?
RTS, S/AS01B, RTS, S/AS02A and Rabipur (Rabies) Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
255 participants
Where
1 siteKenya
Study dates
Jul 2005to Sep 2006
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Kenya1 site

  • U.S. Army Research Unit-Kenya

    Kisumu

Other trials in Kenya

About this study

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.

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.

Read the 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.

Being tested
RTS, S/AS01B, RTS, S/AS02A, Rabipur (Rabies) Vaccine
Medical subject headings
Malaria, Falciparum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RTS, S/AS01BBiological

    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/AS02ABiological

    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) VaccineBiological

    1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months

Study groups in NCT00197054
Study groupRoleWhat they receive
VACC 1 (RTS, S/AS01B)ExperimentalRTS, 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.
Receives: Biological: RTS, S/AS01B
VACC 2 (RTS, S/AS02A)ExperimentalRTS, 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.
Receives: Biological: RTS, S/AS02A
Rabipur (Rabies) VaccineActive comparatorRabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.
Receives: Biological: Rabipur (Rabies) Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 7 day follow-up (day of vaccination + 6 days)

  2. Safety: Number of Administered Doses Eliciting Grade 3 Unsolicited Symptoms

    Grade 3 unsolicited symptoms reported following any number of administered doses

    Measured: 6.5 months

  3. 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)

    Measured: 7 day follow-up period (day of vaccination + 6 days)

Secondary outcomes (4)

  1. Safety: Occurrence of SAEs

    Percentage of subjects experiencing SAEs classified by MedRA System Organ Class and Preferred Term (Month 6.5-12)

    Measured: months 6.5 thru 12

  2. Safety: Occurrence of SAEs

    Percentage of subjects reporting SAEs classified by MedDRA System Organ Class and Preferred Term (Month 0-12)

    Measured: months 0 thru 12

  3. Occurrence of Hematology Parameters Below Normal Range

    Occurrence of hematology parameters below normal range (Total Cohort)

    Measured: Days 0, 6, 66, and 90; Months 6 and 12

  4. Occurrence of Biochemistry Parameters Above Normal Ranges

    Occurrence of parameters of biochemical monitoring above normal ranges (Total Cohort)

    Measured: Days 0, 6, and 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2005 (estimated)
  2. Study startJul 2005
  3. Primary completionSep 2006
  4. Study completionSep 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
255 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00197054
Sponsor's protocol ID
A-12227
Other IDs
IND 11220
Status last verified
Feb 2021
First submitted
13 Sep 2005
Last updated
12 Feb 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: GSK and WRAIR

Publications

  • 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.

    PubMed 19649245

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RTS, S/AS01B, RTS, S/AS02A and Rabipur (Rabies) Vaccine in people with Plasmodium Falciparum, run by U.S. Army Medical Research and Development Command at 1 site in Kenya.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety: Proportion of Subjects With Grade 3 Solicited and Unsolicited General Reactions After Vaccination of RTS, S/AS02A and RTS, S/AS01B (time frame: 7 day follow-up (day of vaccination + 6 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00197054, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2021.

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