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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00051454




Registration number
NCT00051454
Ethics application status
Date submitted
10/01/2003
Date registered
13/01/2003
Date last updated
27/08/2007

Titles & IDs
Public title
Evaluation of the Safety of and Immune Response to an HIV Vaccine in Healthy Adults
Scientific 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
Secondary ID [1] 0 0
N01-AI05395
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and adverse events among the two vaccination groups
Timepoint [1] 0 0
Primary outcome [2] 0 0
lymphoproliferative (LP) responses to HIV antigens, as assessed by LP assays at Week 9
Timepoint [2] 0 0
Primary outcome [3] 0 0
CD8+ T cell responses to HIV antigens, as assessed by ELIspot assay of interferon gamma (IFN-g) secreting cells at Week 9
Timepoint [3] 0 0
Secondary outcome [1] 0 0
Proportion of patients with positive LP assay and ELISPOT assay responses
Timepoint [1] 0 0
Secondary outcome [2] 0 0
intracellular cytokine staining (ICS) of IFN-g/CD69 and flow cytometry
Timepoint [2] 0 0
Secondary outcome [3] 0 0
51-Cr release cytotoxic T cell lymphocyte assay
Timepoint [3] 0 0
Secondary outcome [4] 0 0
HLA class I tetramer analyses
Timepoint [4] 0 0
Secondary outcome [5] 0 0
anti-HIV gag, pol and env antibodies, as assessed by ELISA and Western blot
Timepoint [5] 0 0
Secondary outcome [6] 0 0
behavioral changes in study participants
Timepoint [6] 0 0

Eligibility
Key inclusion criteria
Inclusion Criteria

* HIV negative.
* Acceptable methods of contraception.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria

* 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.
* 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
National Centre in HIV Epidemiology and Clinical Research - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Sydney

Funding & Sponsors
Primary sponsor type
Government body
Name
National Institute of Allergy and Infectious Diseases (NIAID)
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT00051454
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
David A Cooper, MD, DSc
Address 0 0
National Centre in HIV Epidemiology and Clinical Research, University of New South Wales
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00051454