HIV InfectionsPhase 1/2NCT00051454
Evaluation of the Safety of and Immune Response to an HIV Vaccine in Healthy Adults
A Phase 1/2 study testing HIV DNA plasmid vaccine plus recombinant fowlpox vector in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Australia.
Trial summary
This study will examine the safety and immune response to a two-part HIV vaccine. Healthy volunteers who are at low risk of HIV infection will receive either active vaccine or a placebo. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- HIV DNA plasmid vaccine plus recombinant fowlpox vector
- Type of treatment
- Vaccines
- How many people
- 24 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2003to Feb 2005
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- HIV negative.
- Acceptable methods of contraception.
Who cannot join
- Identifiable risk behavior for HIV infection, including: sexual partners of HIV positive people, sexual intercourse with a partner of unknown HIV status if that partner is reported to be at higher risk for HIV infection, gay men reporting any unprotected anal intercourse with partners of unknown status in the 12 months preceding study entry, individuals diagnosed with a sexually transmissible infection (STI) in the 12 months preceding entry that may have been acquired through anal or vaginal intercourse, individuals reporting sharing of injecting equipment in the last 12 months.
- HIV candidate vaccines in a previous HIV vaccine trial.
- Live attenuated vaccines within 60 days prior to entering the study. Whole killed, toxoid, or sub-unit vaccines (e.g., influenza, pneumococcal, tetanus, and hepatitis B) are not exclusionary within 4 weeks prior to the scheduled experimental HIV vaccines.
- Hypersensitivity to egg products or a known history of anaphylaxis or any other serious adverse reactions to vaccination.
- History of serious allergic reaction requiring hospitalization or emergency medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension) to any substance.
- Significant illness requiring immunomodulatory or cytotoxic therapy.
Show all 12Show fewer
- History of cancer unless there is evidence of surgical excision followed by a sufficient observation period to give a reasonable assurance of cure.
- Blood products or immunoglobulins within 6 months prior to entering the study.
- Experimental or investigational agents within 30 days prior to entering the study.
- Recreational and/or therapeutic drug use that might compromise the study participant's safety.
- Medical or psychiatric condition or occupational responsibilities that preclude compliance with the protocol.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
Australia1 site
National Centre in HIV Epidemiology and Clinical Research
Sydney, New South Wales, 2010
About this study
Official title: A Randomised, Placebo-Controlled, Double-Blind, Phase I/IIa Clinical Trial to Evaluate the Safety and Immunogenicity of a Candidate Prophylactic DNA Prime-rFPV Boost HIV Vaccination Strategy
This study will examine the safety and immune response to a two-part HIV vaccine. Healthy volunteers who are at low risk of HIV infection will receive either active vaccine or a placebo.
Read the detailed description
The purpose of this study is to examine the safety and immunogenicity of a candidate vaccine strategy for HIV prophylaxis using a DNA-prime plus recombinant fowlpox boost. The DNA plasmid and fowlpox vector contain HIV genes. However, these vaccines contain only some HIV genes and cannot themselves cause HIV or AIDS.
Eligible volunteers at low risk of HIV infection will be randomized to receive either active vaccine or placebo injections at Day 0, Week 4, and Week 8. Intensive immunologic and safety monitoring will be done during the first 16 weeks of the study. Follow-up will continue to Week 52.
- Conditions
- HIV Infections
- Being tested
- HIV DNA plasmid vaccine plus recombinant fowlpox vector
- Keywords
- HIV Seronegativity, HIV Preventive Vaccine
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV DNA plasmid vaccine plus recombinant fowlpox vectorBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and adverse events among the two vaccination groups
lymphoproliferative (LP) responses to HIV antigens, as assessed by LP assays at Week 9
CD8+ T cell responses to HIV antigens, as assessed by ELIspot assay of interferon gamma (IFN-g) secreting cells at Week 9
Secondary outcomes (6)
Proportion of patients with positive LP assay and ELISPOT assay responses
intracellular cytokine staining (ICS) of IFN-g/CD69 and flow cytometry
51-Cr release cytotoxic T cell lymphocyte assay
HLA class I tetramer analyses
anti-HIV gag, pol and env antibodies, as assessed by ELISA and Western blot
behavioral changes in study participants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2003 (estimated)
- Study startMar 2003
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 24 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- David A Cooper, MD, DSc, Study director, National Centre in HIV Epidemiology and Clinical Research, University of New South Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00051454
- Sponsor's protocol ID
- N01-AI05395
- Status last verified
- Aug 2007
- First submitted
- 10 Jan 2003
- Last updated
- 27 Aug 2007
- Results posted
- No
Publications
Kelleher AD, Puls RL, Bebbington M, Boyle D, Ffrench R, Kent SJ, Kippax S, Purcell DF, Thomson S, Wand H, Cooper DA, Emery S. A randomized, placebo-controlled phase I trial of DNA prime, recombinant fowlpox virus boost prophylactic vaccine for HIV-1. AIDS. 2006 Jan 9;20(2):294-7. doi: 10.1097/01.aids.0000199819.40079.e9.
PubMed 16511428
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Placebo-Controlled, Double-Blind, Phase I/IIa Clinical Trial to Evaluate the Safety and Immunogenicity of a Candidate Prophylactic DNA Prime-rFPV Boost HIV Vaccination Strategy
- ClinicalTrials.gov ID
- NCT00051454
- Acronym / sponsor ID
- N01-AI05395
- Conditions
- HIV Infections
- Keywords
- HIV Seronegativity, HIV Preventive Vaccine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Mar 2003
- Study completion
- Feb 2005
- First posted
- 13 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine the safety and immune response to a two-part HIV vaccine. Healthy volunteers who are at low risk of HIV infection will receive either active vaccine or a placebo.
Detailed description
The purpose of this study is to examine the safety and immunogenicity of a candidate vaccine strategy for HIV prophylaxis using a DNA-prime plus recombinant fowlpox boost. The DNA plasmid and fowlpox vector contain HIV genes. However, these vaccines contain only some HIV genes and cannot themselves cause HIV or AIDS.
Eligible volunteers at low risk of HIV infection will be randomized to receive either active vaccine or placebo injections at Day 0, Week 4, and Week 8. Intensive immunologic and safety monitoring will be done during the first 16 weeks of the study. Follow-up will continue to Week 52.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- HIV negative.
- Acceptable methods of contraception.
Key exclusion criteria (12 listed)
- Identifiable risk behavior for HIV infection, including: sexual partners of HIV positive people, sexual intercourse with a partner of unknown HIV status if that partner is reported to be at higher risk for HIV infection, gay men reporting any unprotected anal intercourse with partners of unknown status in the 12 months preceding study entry, individuals diagnosed with a sexually transmissible infection (STI) in the 12 months preceding entry that may have been acquired through anal or vaginal intercourse, individuals reporting sharing of injecting equipment in the last 12 months.
- HIV candidate vaccines in a previous HIV vaccine trial.
- Live attenuated vaccines within 60 days prior to entering the study. Whole killed, toxoid, or sub-unit vaccines (e.g., influenza, pneumococcal, tetanus, and hepatitis B) are not exclusionary within 4 weeks prior to the scheduled experimental HIV vaccines.
- Hypersensitivity to egg products or a known history of anaphylaxis or any other serious adverse reactions to vaccination.
- History of serious allergic reaction requiring hospitalization or emergency medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension) to any substance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIV DNA plasmid vaccine plus recombinant fowlpox vector | Biological | – |
Primary outcome
Safety and adverse events among the two vaccination groups
lymphoproliferative (LP) responses to HIV antigens, as assessed by LP assays at Week 9
CD8+ T cell responses to HIV antigens, as assessed by ELIspot assay of interferon gamma (IFN-g) secreting cells at Week 9
6 secondary outcomes
Proportion of patients with positive LP assay and ELISPOT assay responses
intracellular cytokine staining (ICS) of IFN-g/CD69 and flow cytometry
51-Cr release cytotoxic T cell lymphocyte assay
HLA class I tetramer analyses
anti-HIV gag, pol and env antibodies, as assessed by ELISA and Western blot
behavioral changes in study participants
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2007.
- Results publication: PubMed 16511428Kelleher AD, Puls RL, Bebbington M, Boyle D, Ffrench R, Kent SJ, Kippax S, Purcell DF, Thomson S, Wand H, Cooper DA, Emery S. A randomized, placebo-controlled phase I trial of DNA prime, recombinant fowlpox virus boost prophylactic vaccine for HIV-1. AIDS. 2006 Jan 9;20(2):294-7. doi: 10.1097/01.aids.0000199819.40079.e9.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A Cooper, MD, DSc study director
National Centre in HIV Epidemiology and Clinical Research, University of New South Wales
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HIV DNA plasmid vaccine plus recombinant fowlpox vector in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Australia.
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 12 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 27 Aug 2007. 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 Australia. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 and adverse events among the two vaccination groups. 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 NCT00051454, 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 27 Aug 2007.