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
NCT ID: NCT01371175
Last Updated: 2011-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
115 participants
INTERVENTIONAL
2003-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Group A
DNA 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
DNA.HIVA
0.5mg DNA.HIVA or placebo
MVA.HIVA
5x10\^6 pfu MVA or placebo
Group B
DNA 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
DNA.HIVA
0.5mg DNA.HIVA or placebo
MVA.HIVA
5x10\^6 pfu MVA or placebo
Group C
DNA 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
DNA.HIVA
0.5mg DNA.HIVA or placebo
MVA.HIVA
5x10\^7 pfu MVA or placebo
Group D
DNA 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
DNA.HIVA
0.5mg DNA.HIVA or placebo
MVA.HIVA
5x10\^7 pfu MVA or placebo
Group E
DNA 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
DNA.HIVA
0.5mg DNA.HIVA or placebo
MVA.HIVA
5x10\^7 pfu MVA or placebo
MVA.HIVA
2.5x10\^8 pfu MVA or placebo
Group F
DNA 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
DNA.HIVA
0.5mg DNA.HIVA or placebo
MVA.HIVA
2.5x10\^8 pfu MVA or placebo
Group G
DNA 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
DNA.HIVA
0.5mg DNA.HIVA or placebo
Groups C2/D2/E2 (Subgroups of C,D,E)
DNA 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.
DNA.HIVA
0.5mg DNA.HIVA or placebo
MVA.HIVA
5x10\^7 pfu MVA or placebo
Group F2/G2 (Subgroup of F and G)
DNA 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.
DNA.HIVA
0.5mg DNA.HIVA or placebo
MVA.HIVA
2.5x10\^8 pfu MVA or placebo
Interventions
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DNA.HIVA
0.5mg DNA.HIVA or placebo
MVA.HIVA
5x10\^6 pfu MVA or placebo
MVA.HIVA
5x10\^7 pfu MVA or placebo
MVA.HIVA
2.5x10\^8 pfu MVA or placebo
Eligibility Criteria
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Inclusion Criteria
2. Age at least 18 years on the day of screening and no greater than 60 years on the day of enrolment;
3. Available for follow up for the planned duration of the study (screening plus 18 months);
4. Able to give written informed consent;
5. Does not engage in risk behaviour as defined by the protocol, willing to undergo HIV testing and receive results;
6. 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;
7. If sexually active male, willing to use an effective method of contraception (such as condoms) from screening until 4 months after the last vaccination.
Exclusion Criteria
2. Presence of any chronic condition;
3. 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.
4. If female, pregnant or planning a pregnancy within 4 months after last vaccination or lactating;
5. Receipt of live attenuated vaccine within 60 days or other vaccine within 14 days of enrolment;
6. Receipt of blood transfusion or blood products 6 months prior to enrolment;
7. Participation in another clinical trial of an investigational product currently or within last 12 weeks or expected participation during this study;
8. History of severe local or general reaction to vaccination or history of allergic reactions;
9. History of grand-mal epilepsy, or currently taking anti-epileptics;
10. Confirmed HIV-1 or HIV-2 seropositive;
11. 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;
12. Unlikely to comply with protocol. Prior receipt of smallpox vaccination should be documented, but will not be an exclusion criterion.
18 Years
60 Years
ALL
Yes
Sponsors
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Medical Research Council-Oxford
UNKNOWN
University of Nairobi
OTHER
International AIDS Vaccine Initiative
NETWORK
Responsible Party
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International AIDS Vaccine Initiative
Principal Investigators
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Barry S. Peters, MD
Role: PRINCIPAL_INVESTIGATOR
Guys and St. Thomas' Hospital
Walter Jaoko
Role: PRINCIPAL_INVESTIGATOR
KAVI (Kenya AIDS Vaccine Initiative)
Locations
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KAVI (Kenya AIDS Vaccine Initiative)
Nairobi, , Kenya
Guys and St. Thomas' Hospital
London, , United Kingdom
Countries
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Related Links
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International AIDS Vaccine Initiative
Other Identifiers
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IAVI 010
Identifier Type: -
Identifier Source: org_study_id
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