HIVPhase 1/2NCT00333424
Thai Prophylactic HIV Vaccine Phase I Study
A Phase 1/2 study testing pHIS-HIV-AE (DNA vaccine) prime and rFPV-HIV-AE (recombinant fowlpox virus boost) vaccine in people with HIV, run by Kirby Institute at 1 site in Thailand.
Trial summary
The development of a safe and effective vaccine for HIV is the subject of intensive world-wide research. Various approaches are being investigated in monkey models and humans. This is a randomized, double-blind trial to evaluate the safety and immunogenicity of a candidate preventative human immunodeficiency virus… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- pHIS-HIV-AE (DNA vaccine) prime and rFPV-HIV-AE (recombinant fowlpox virus boost) vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteThailand
- Study dates
- Aug 2007to Feb 2009
- 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
- Healthy volunteers, as judged by the screening physician based on medical history, physical examination and laboratory results
- 18 - 55 years of age, inclusive
- Laboratory blood values within clinically acceptable range
- Women of reproductive potential must have a negative urine beta-human chorionic gonadotropin (B-HCG) pregnancy test at both the screening and baseline visits
- Agreement to employ barrier contraception for 4 weeks preceding entry and for the whole duration of the study (52 weeks)
- Agreement to undertake HIV testing and to receive results
- Provision of written informed consent approved by the Institutional Ethics Committee (IEC).
Who cannot join
- HIV positive
- HBsAg or HCV positive
- Identifiable risk behaviour for HIV infection, defined as any one of the following:
- sexual partners of HIV positive people
- individuals reporting unprotected intercourse with a partner of unknown HIV status, if that partner is reported to be at higher risk for HIV infection ("higher risk of HIV infection" is defined as individuals reporting unprotected anal intercourse (UAI), unprotected intercourse with sex workers and/or sharing injecting equipment within the 12 months preceding trial entry
- men reporting any UAI with male partners of unknown status in the 12 months preceding entry to the study
Show all 18Show fewer
- individuals who in the 12 months preceding entry to the study have been diagnosed with a new sexually transmissible infection (STI) that may have been acquired through anal or vaginal intercourse (receptive or insertive)
- individuals reporting sharing of injecting equipment in the last 12 months
- Recipients of prior HIV candidate vaccines in a previous HIV vaccine trial (does not apply to volunteers who received placebo or adjuvant in such a trial)
- Recipients of live attenuated vaccines within 60 days prior to entering the study. Whole killed, toxoid or sub-unit vaccines e.g. influenza, pneumococcus, tetanus, hepatitis B are not exclusionary when given at least 4 weeks prior to the scheduled experimental HIV vaccines
- Known or suspected hypersensitivity to egg products or a known history of anaphylaxis or any other serious adverse reactions to any vaccinations
- History of serious allergic reactions requiring hospitalisation or emergency medical care (e.g. Steven-Johnson's syndrome, bronchospasm or hypotension) to any substance
- Clinically significant intercurrent illness or a history of clinically significant illness requiring immunomodulatory (including corticosteroids) or cytotoxic treatment (e.g. cancer) or any significant disease conditions that in the opinion of the Principal Investigator precludes the individual from participating in the study
- Recipients of blood products or immunoglobulins within 6 months prior to entering the study
- Recipients of experimental or investigational agents within 30 days prior to entering the study
- Recreational and/or therapeutic drug-use that, in the opinion of the Principal Investigator, might compromise the volunteer's participation in any way
- Medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol
- Pregnant or lactating women, or women planning to become pregnant during the trial.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
HIV-NAT (The HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Centre
Bangkok, 10330
About this study
Official title: A Randomised, Placebo-Controlled, Double-Blind, Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of a Candidate Prophylactic pHIS-HIV-AE DNA Prime and rFPV-HIV-AE Boost HIV Vaccination Strategy
The development of a safe and effective vaccine for HIV is the subject of intensive world-wide research. Various approaches are being investigated in monkey models and humans. This is a randomized, double-blind trial to evaluate the safety and immunogenicity of a candidate preventative human immunodeficiency virus (HIV) vaccine strategy in 24 healthy adult Thai volunteers with no identifiable risk behaviour for HIV-1 infection. Volunteers will receive three "priming" vaccinations at weeks 0, 4 and 8 (pHIS-HIV-AE, a DNA vector delivering AE clade HIV-1 genes). This will be followed at week 12 by single "boost" vaccination (rFPV-HIV-AE, non-replicating, recombinant fowlpox virus vector delivering the same HIV-1 genes). Safety and immunological monitoring will continue to 52 weeks
- Conditions
- HIV
- Being tested
- pHIS-HIV-AE (DNA vaccine) prime and rFPV-HIV-AE (recombinant fowlpox virus boost) vaccine
- Keywords
- HIV, Human Immunodeficiency Virus, Prophylactic vaccine
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pHIS-HIV-AE (DNA vaccine) prime and rFPV-HIV-AE (recombinant fowlpox virus boost) vaccineBiological
6mg pHIS-HIV-AE at weeks 0, 4 and 8; 3 x 10e8 pfu/mL rFPV-HIV-AE at week 12
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | placebo containing diluent alone Receives: Biological: pHIS-HIV-AE (DNA vaccine) prime and rFPV-HIV-AE (recombinant fowlpox virus boost) vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
All safety data summarised & compared by randomly assigned vaccination group. Primary immunological outcome is mean difference in change in percent of IFN-y + CD4+ and/or CD8+ cells by intracellular cytokine staining (ICCS) from week 0 to 13.
Measured: 13 weeks
Secondary outcomes (1)
Proportion of patients with positive ICCS assay responses; peripheral blood mononuclear cell responses to HIV antigens; proportion of patients with positive ELIspot assay responses; anti-HIV Gag, Pol & Env antibodies.
Measured: week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2006 (estimated)
- Study startAug 2007
- Primary completionJul 2008
- Study completionFeb 2009
Why it stopped: Vaccines safe but not immunogenic in 8 participants; trial closed to further recruitment by the protocol steering committee \& DSMB.
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 HIVStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Collaborators
- Thai Red Cross AIDS Research Centre
- Responsible party
- Sponsor
- Investigators
- Kiat Ruxrungtham, MD PhD, Principal investigator, HIV-NAT, Thai Red Cross AIDS Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00333424
- Sponsor's protocol ID
- NCHECR-AE1
- Status last verified
- Jun 2012
- First submitted
- 1 Jun 2006
- Last updated
- 13 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hemachandra A, Puls RL, Sirivichayakul S, Kerr S, Thantiworasit P, Ubolyam S, Cooper DA, Emery S, Phanuphak P, Kelleher A, Ruxrungtham K. An HIV-1 clade A/E DNA prime, recombinant fowlpox virus boost vaccine is safe, but non-immunogenic in a randomized phase I/IIa trial in Thai volunteers at low risk of HIV infection. Hum Vaccin. 2010 Oct;6(10):835-40. doi: 10.4161/hv.6.10.12635. Epub 2010 Oct 1.
PubMed 20864808
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Placebo-Controlled, Double-Blind, Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of a Candidate Prophylactic pHIS-HIV-AE DNA Prime and rFPV-HIV-AE Boost HIV Vaccination Strategy
- ClinicalTrials.gov ID
- NCT00333424
- Acronym / sponsor ID
- NCHECR-AE1
- Conditions
- HIV
- Keywords
- HIV, Human Immunodeficiency Virus, Prophylactic vaccine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Vaccines safe but not immunogenic in 8 participants; trial closed to further recruitment by the protocol steering committee \& DSMB.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Kirby InstituteOther government
- Collaborators
- Thai Red Cross AIDS Research Centre
- Study start
- Aug 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 5 Jun 2006 (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.
The development of a safe and effective vaccine for HIV is the subject of intensive world-wide research. Various approaches are being investigated in monkey models and humans. This is a randomized, double-blind trial to evaluate the safety and immunogenicity of a candidate preventative human immunodeficiency virus (HIV) vaccine strategy in 24 healthy adult Thai volunteers with no identifiable risk behaviour for HIV-1 infection. Volunteers will receive three "priming" vaccinations at weeks 0, 4 and 8 (pHIS-HIV-AE, a DNA vector delivering AE clade HIV-1 genes). This will be followed at week 12 by single "boost" vaccination (rFPV-HIV-AE, non-replicating, recombinant fowlpox virus vector delivering the same HIV-1 genes). Safety and immunological monitoring will continue to 52 weeks
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Biological: pHIS-HIV-AE (DNA vaccine) prime and rFPV-HIV-AE (recombinant fowlpox virus boost) vaccineplacebo containing diluent alone |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy volunteers, as judged by the screening physician based on medical history, physical examination and laboratory results
- 18 - 55 years of age, inclusive
- Laboratory blood values within clinically acceptable range
- Women of reproductive potential must have a negative urine beta-human chorionic gonadotropin (B-HCG) pregnancy test at both the screening and baseline visits
- Agreement to employ barrier contraception for 4 weeks preceding entry and for the whole duration of the study (52 weeks)
Key exclusion criteria (18 listed)
- HIV positive
- HBsAg or HCV positive
- Identifiable risk behaviour for HIV infection, defined as any one of the following:
- Recipients of prior HIV candidate vaccines in a previous HIV vaccine trial (does not apply to volunteers who received placebo or adjuvant in such a trial)
- Recipients of live attenuated vaccines within 60 days prior to entering the study. Whole killed, toxoid or sub-unit vaccines e.g. influenza, pneumococcus, tetanus, hepatitis B are not exclusionary when given at least 4 weeks prior to the scheduled experimental HIV vaccines
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 |
|---|---|---|
| pHIS-HIV-AE (DNA vaccine) prime and rFPV-HIV-AE (recombinant fowlpox virus boost) vaccine6mg pHIS-HIV-AE at weeks 0, 4 and 8; 3 x 10e8 pfu/mL rFPV-HIV-AE at week 12 | Biological | Placebo |
Primary outcome
All safety data summarised & compared by randomly assigned vaccination group. Primary immunological outcome is mean difference in change in percent of IFN-y + CD4+ and/or CD8+ cells by intracellular cytokine staining (ICCS) from week 0 to 13.
Time frame: 13 weeks
1 secondary outcome
Proportion of patients with positive ICCS assay responses; peripheral blood mononuclear cell responses to HIV antigens; proportion of patients with positive ELIspot assay responses; anti-HIV Gag, Pol & Env antibodies.
Time frame: week 13
Results and safety
The study was stopped early (reason given: Vaccines safe but not immunogenic in 8 participants; trial closed to further recruitment by the protocol steering committee \& DSMB.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2012.
- Results publication: PubMed 20864808Hemachandra A, Puls RL, Sirivichayakul S, Kerr S, Thantiworasit P, Ubolyam S, Cooper DA, Emery S, Phanuphak P, Kelleher A, Ruxrungtham K. An HIV-1 clade A/E DNA prime, recombinant fowlpox virus boost vaccine is safe, but non-immunogenic in a randomized phase I/IIa trial in Thai volunteers at low risk of HIV infection. Hum Vaccin. 2010 Oct;6(10):835-40. doi: 10.4161/hv.6.10.12635. Epub 2010 Oct 1.
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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.
Kiat Ruxrungtham, MD PhD principal investigator
HIV-NAT, Thai Red Cross AIDS Research Center
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 pHIS-HIV-AE (DNA vaccine) prime and rFPV-HIV-AE (recombinant fowlpox virus boost) vaccine in people with HIV, run by Kirby Institute at 1 site in Thailand.
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 7 inclusion and 18 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: stopped early, as of the sponsor's last update on 13 Jun 2012. 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 Thailand. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Vaccines safe but not immunogenic in 8 participants; trial closed to further recruitment by the protocol steering committee \& DSMB.). Results are not available in the source record.
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?
All safety data summarised & compared by randomly assigned vaccination group. Primary immunological outcome is mean difference in change in percent of IFN-y + CD4+ and/or CD8+ cells by intracellular cytokine staining (ICCS) from week 0 to 13. (time frame: 13 weeks). 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 NCT00333424, 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 13 Jun 2012.