A Phase IIA Trial to Evaluate the Safety and Immunogenicity of a DNA HIV-1 Vaccine Followed by an MVA HIV-1 Vaccine in HIV-uninfected Volunteers
A Randomized, Placebo-Controlled, Dosage-Escalating Phase 2A Study, Double-Blinded With Respect to Assignment to Either Vaccine or Placebo, to Evaluate the Safety and Immunogenicity of a DNA HIV-1 Vaccine Administered Intramuscularly Followed by an MVA HIV-1 Vaccine Administered at Three Different Dosage Levels and by Three Different Routes to HIV-Uninfected, Healthy, Volunteers.
1 other identifier
interventional
115
2 countries
2
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of plasmid DNA and recombinant MVA (Modified Vaccinia Virus Ankara) in a prime-boost regimen. Approximately 111 volunteers (90 vaccine recipients/21 placebo recipients) will be enrolled at two sites. Approximately 56 volunteers will be enrolled at each site. An over-enrolment of up to 10% (approximately 10 additional volunteers) will be permitted in the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hiv-infections
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 31, 2011
CompletedFirst Posted
Study publicly available on registry
June 10, 2011
CompletedJune 10, 2011
June 1, 2011
2.1 years
May 31, 2011
June 9, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety (local and systemic reactogenicity signs and symptoms, laboratory measures, and adverse events)
18 months
Secondary Outcomes (1)
Immunogenicity: Proportion of volunteers with HIV-1 specific T-cell responses by ELISPOT assay.
Day 0, Month 1, Month 2, Month 5, Month 6, Month 8, Month 9, Month 12, Month 18
Study Arms (9)
Group A
EXPERIMENTALDNA or Placebo delivered intramuscularly at Months 0 and 1 followed by MVA or Placebo at Months 5 and 8 delivered subcutaneously. Vaccine:Placebo =12/3
Group B
EXPERIMENTALDNA or Placebo delivered intramuscularly at Months 0 and 1 followed by MVA or Placebo at Months 5 and 8 delivered intramuscularly. Vaccine:Placebo =12/3
Group C
EXPERIMENTALDNA or Placebo delivered intramuscularly at Months 0 and 1 followed by MVA or Placebo at Months 5 and 8 delivered intradermally. Vaccine:Placebo =18/3
Group D
EXPERIMENTALDNA or Placebo delivered intramuscularly at Months 0 and 1 followed by MVA or Placebo at Months 5 and 8 delivered subcutaneously. Vaccine:Placebo =12/3
Group E
EXPERIMENTALDNA or Placebo delivered intramuscularly at Months 0 and 1 followed by MVA or Placebo at Months 5 and 8 delivered intramuscularly. Vaccine:Placebo =12/3
Group F
EXPERIMENTALDNA or Placebo delivered intramuscularly at Months 0 and 1 followed by MVA or Placebo at Months 5 and 8 delivered subcutaneously. Vaccine:Placebo =12/3
Group G
EXPERIMENTALDNA or Placebo delivered intramuscularly at Months 0 and 1 followed by MVA or Placebo at Months 5 and 8 delivered intramuscularly. Vaccine:Placebo =12/3
Groups C2/D2/E2 (Subgroups of C,D,E)
EXPERIMENTALDNA or Placebo delivered intramuscularly at Months 0 and 1 followed by MVA or Placebo at Months 5 and Month 12+ (volunteers offered second MVA/placebo more than 12 months (late boost) after their enrollment into their original treatment assignment) delivered ID, SC, or IM according to original randomization. Vaccine:Placebo = blinded ratio, maximum in C2/D2/E2 = 16.
Group F2/G2 (Subgroup of F and G)
EXPERIMENTALDNA or Placebo delivered intramuscularly at Months 0 and 1 followed by MVA or Placebo at Months 5 and Month 12+ (volunteers offered second MVA/placebo more than 12 months (late boost) after their enrollment into their original treatment assignment) delivered either SC or IM according to original randomization. Vaccine:Placebo = blinded ratio, maximum in F/G= 29.
Interventions
Eligibility Criteria
You may qualify if:
- Healthy males and females;
- Age at least 18 years on the day of screening and no greater than 60 years on the day of enrolment;
- Available for follow up for the planned duration of the study (screening plus 18 months);
- Able to give written informed consent;
- Does not engage in risk behaviour as defined by the protocol, willing to undergo HIV testing and receive results;
- If sexually active female, using an effective method of contraception (combined oral contraceptive pill; injectable contraceptive; IUCD; condoms; anatomical sterility in self or partner) from screening until at least 4 months after last vaccination and willing to undergo urine pregnancy tests at screening and prior to each vaccination and 4 months after the last vaccination;
- If sexually active male, willing to use an effective method of contraception (such as condoms) from screening until 4 months after the last vaccination.
You may not qualify if:
- Clinically relevant abnormality on history or examination including history of immunodeficiency or use of systemic corticosteroids, immunosuppressive, antiviral, anticancer, or other medications considered significant by the designated trial physician in last 6 months;
- Presence of any chronic condition;
- Any of the following abnormal laboratory parameters that are moderate, severe, or very severe: haematology (haemoglobin, absolute neutrophil count absolute lymphocyte count , absolute CD4 count, platelets); urinalysis, biochemistries (total bilirubin, creatinine, AST, ALT). Volunteers with mild laboratory abnormalities which are judged by the principal investigator or designee to be not clinically significant may be enrolled.
- If female, pregnant or planning a pregnancy within 4 months after last vaccination or lactating;
- Receipt of live attenuated vaccine within 60 days or other vaccine within 14 days of enrolment;
- Receipt of blood transfusion or blood products 6 months prior to enrolment;
- Participation in another clinical trial of an investigational product currently or within last 12 weeks or expected participation during this study;
- History of severe local or general reaction to vaccination or history of allergic reactions;
- History of grand-mal epilepsy, or currently taking anti-epileptics;
- Confirmed HIV-1 or HIV-2 seropositive;
- Positive for hepatitis B (surface antigen) or confirmed diagnosis of active syphilis at the time of enrolment (RPR positive and TPHA positive or equivalent), positive for hepatitis C antibodies;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- International AIDS Vaccine Initiativelead
- Medical Research Council-Oxfordcollaborator
- University of Nairobicollaborator
Study Sites (2)
KAVI (Kenya AIDS Vaccine Initiative)
Nairobi, Kenya
Guys and St. Thomas' Hospital
London, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barry S. Peters, MD
Guys and St. Thomas' Hospital
- PRINCIPAL INVESTIGATOR
Walter Jaoko
KAVI (Kenya AIDS Vaccine Initiative)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
Study Record Dates
First Submitted
May 31, 2011
First Posted
June 10, 2011
Study Start
April 1, 2003
Primary Completion
May 1, 2005
Last Updated
June 10, 2011
Record last verified: 2011-06