HIV InfectionsPhase 2NCT01933685
Study of Immune Responses Induced by a HIV Vaccine
A Phase 2 study testing AIDSVAX B/E in people with HIV Infections, run by U.S. Army Medical Research and Development Command at 1 site in Thailand.
Trial summary
The purpose of this study is to define the immune responses induced by a HIV vaccine, AIDSVAX B/E. Blood and mucosal samples will be collected to assess immune responses. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- AIDSVAX B/E
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- 3 Jul 2014to May 2020
- Phase
- Phase 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female volunteers between age 20 and 40, available for follow up in Bangkok for a period of 18 months and having a Thai identification card.
- Must be at low risk for HIV infection per investigator assessment.
- Can read and write Thai language and must be able to understand and complete the informed consent process.
- Must successfully complete a Test of Understanding (TOU) prior to enrollment.
- Must be in good general health without clinically significant medical history.
- HIV-uninfected per diagnostic algorithm within 45 days of enrollment.
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- Laboratory screening analysis (within normal institutional range):
- Hemoglobin: Women >/= 12.0 g/dL, Men >/= 12.5 g/dL
- White cell count: 4,000 to 11,000 cells/mm^3
- Platelets: 150,000 to 450,000/mm^3
- ALT and AST </= 1.25 institutional upper limit of reference range
- Creatinine: </= 1.25 institutional upper limit of reference range
- Urinalysis (dipstick) for blood and protein no greater than 1+, glucose negative
- Female-Specific Criteria:
- Negative human choriogonadotropin (β-HCG) urine pregnancy test for women at screening and prior to each vaccination (same day), and prior to invasive procedures.
- Use of adequate birth control methods followed for 45 days prior to the first vaccine/placebo vaccination and will continue to be followed for at least 3 months after the final vaccine/placebo vaccination. Adequate birth control is defined as follows: Contraceptive medications delivered orally, intramuscularly, vaginally, or implanted underneath the skin, surgical methods (hysterectomy or bilateral tubal ligation), condoms, diaphragms, intrauterine device (IUD), or abstinence.
Who cannot join
- Active, untreated syphilis
- Asplenia: any condition resulting in the absence of a functional spleen
- Bleeding disorder diagnosed by a medical doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions), therapeutic anticoagulation resulting in an abnormal prothrombin (PT) / international normalized ration (INR) of partial prothrombin time (PTT)
- Women breast-feeding or pregnant (positive pregnancy test) or planning to become pregnant during the window between study enrollment and 3 months after the last vaccination visit.
- Male or female who has exchanged money or goods for sex in the last 12 months.
- An intravenous drug user in the last 12 months.
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- History of anaphylaxis or other serious adverse reaction to vaccines any time in the past, or allergies or reactions likely to be exacerbated by any component of the vaccine or placebo, including streptomycin or neomycin.
- Subject has received any of the following substances:
- Chronic use of therapies that may modify immune response, such as IV immune globulin and systemic corticosteroids (in doses of >/= 20 mg/day prednisone equivalent for periods exceeding 10 days). The following exceptions are permitted and will not exclude study participation: use of corticosteroid nasal spray for rhinitis, topical corticosteroids for an acute uncomplicated dermatitis; or a short course (duration of 10 days or less, or a single injection) of corticosteroid for a non-chronic condition (based on investigator clinical judgment) at least 2 weeks prior to enrollment in this study.
- Blood products within 120 days prior to HIV screening.
- Immunoglobulins within 30 days prior to HIV screening.
- Any licensed vaccine within 14 days prior to initial study vaccine administration in the present study.
- Receipt of any investigational HIV vaccine.
- Investigational research agents or vaccine within 30 days prior to initial study vaccine administration in the present study.
- Use of anti-tuberculosis prophylaxis or therapy during the past 90 days.
- Any medical, psychiatric, social condition, occupational reason, or other responsibility that, in the judgment of the investigator, is a contraindication to protocol compliance or impairs a subjects ability to give informed consent.
- Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder; disorder requiring lithium; or within 5 years prior to enrollment, a history of suicide ideation or attempt.
- Study site employees who are involved in the protocol and/or may have direct access to study related area.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double Blind Evaluation of Sequential Administration of gp120 B/E (AIDSVAX B/E) (GSID) With 1-Year Boosting in HIV-uninfected Thai Adults
The purpose of this study is to define the immune responses induced by a HIV vaccine, AIDSVAX B/E. Blood and mucosal samples will be collected to assess immune responses.
Read the detailed description
The primary purpose of this study is to define in HIV-uninfected volunteers the innate, cell-mediated and humoral responses induced by AIDSVAX B/E in the systemic and mucosal compartments and to characterize B cell functional specificities in peripheral blood, bone marrow and sigmoid compartments.
- Conditions
- HIV Infections
- Being tested
- AIDSVAX B/E, AIDSVAX B/E Placebo
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIDSVAX B/EBiological
1 mL per injection (300 ug dose/antigen for a total of 600 ug/dose administered)
AIDSVAX B/E PlaceboBiological
1 mL per injection
| Study group | Role | What they receive |
|---|---|---|
| AIDSVAX B/E | Experimental | AIDSVAX B/E at Weeks 0, 4, 24 and 48 Receives: Biological: AIDSVAX B/E |
| AIDSVAX B/E Placebo | Placebo comparator | AIDSVAX B/E Placebo at Weeks 0, 4, 24 and 48 Receives: Biological: AIDSVAX B/E Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Immune Response
Characterization of vaccine-induced immune responses in the systemic and mucosal compartments by intracellular cytokine staining (ICS) and IFN-gamma ELISPOT at Baseline, Weeks 4, 6, 24, 26, 48, 50 and 72.
Measured: Through Week 72
Change in Humoral Response
Characterization of vaccine-induced humoral immune response in the systemic and mucosal compartments by binding and neutralizing antibodies at Baseline, Weeks 4, 6, 24, 26, 48, 50 and 72.
Measured: Through Week 72
Secondary outcomes (1)
Safety Monitoring
Post-vaccination reactions including erythema, induration, pain/tenderness, swelling and limitation of arm movement, fever, tiredness, chills, myalgia, arthralgia, headache, nausea, dizziness, and rash will be assessed and recorded on diary cards during the 3 days post-vaccination.
Measured: Through Week 49
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2013 (estimated)
- Study start3 Jul 2014
- Primary completion24 May 2016
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Nittaya Phanuphak,, MD, PhD, Principal investigator, Thai Red Cross AIDS Research CentreJintanat Ananworanich, MD, PhD, Study chair, US Military HIV Research Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01933685
- Sponsor's protocol ID
- RV 328
- Other IDs
- 1939, S-11-0005
- Status last verified
- Sep 2019
- First submitted
- 13 Aug 2013
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind Evaluation of Sequential Administration of gp120 B/E (AIDSVAX B/E) (GSID) With 1-Year Boosting in HIV-uninfected Thai Adults
- ClinicalTrials.gov ID
- NCT01933685
- Acronym / sponsor ID
- RV 328
- Conditions
- HIV Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 3 Jul 2014 (actual)
- Primary completion
- 24 May 2016 (actual)
- Study completion
- May 2020 (estimated)
- First posted
- 2 Sep 2013 (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 purpose of this study is to define the immune responses induced by a HIV vaccine, AIDSVAX B/E. Blood and mucosal samples will be collected to assess immune responses.
Detailed description
The primary purpose of this study is to define in HIV-uninfected volunteers the innate, cell-mediated and humoral responses induced by AIDSVAX B/E in the systemic and mucosal compartments and to characterize B cell functional specificities in peripheral blood, bone marrow and sigmoid compartments.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AIDSVAX B/E | Experimental | Biological: AIDSVAX B/EAIDSVAX B/E at Weeks 0, 4, 24 and 48 |
| AIDSVAX B/E Placebo | Placebo comparator | Biological: AIDSVAX B/E PlaceboAIDSVAX B/E Placebo at Weeks 0, 4, 24 and 48 |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Healthy male or female volunteers between age 20 and 40, available for follow up in Bangkok for a period of 18 months and having a Thai identification card.
- Must be at low risk for HIV infection per investigator assessment.
- Can read and write Thai language and must be able to understand and complete the informed consent process.
- Must successfully complete a Test of Understanding (TOU) prior to enrollment.
- Must be in good general health without clinically significant medical history.
Key exclusion criteria (18 listed)
- Active, untreated syphilis
- Asplenia: any condition resulting in the absence of a functional spleen
- Bleeding disorder diagnosed by a medical doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions), therapeutic anticoagulation resulting in an abnormal prothrombin (PT) / international normalized ration (INR) of partial prothrombin time (PTT)
- Women breast-feeding or pregnant (positive pregnancy test) or planning to become pregnant during the window between study enrollment and 3 months after the last vaccination visit.
- Male or female who has exchanged money or goods for sex in the last 12 months.
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 |
|---|---|---|
| AIDSVAX B/E1 mL per injection (300 ug dose/antigen for a total of 600 ug/dose administered) | Biological | AIDSVAX B/E |
| AIDSVAX B/E Placebo1 mL per injection | Biological | AIDSVAX B/E Placebo |
Primary outcome
Change in Immune Response
Time frame: Through Week 72
Characterization of vaccine-induced immune responses in the systemic and mucosal compartments by intracellular cytokine staining (ICS) and IFN-gamma ELISPOT at Baseline, Weeks 4, 6, 24, 26, 48, 50 and 72.
Change in Humoral Response
Time frame: Through Week 72
Characterization of vaccine-induced humoral immune response in the systemic and mucosal compartments by binding and neutralizing antibodies at Baseline, Weeks 4, 6, 24, 26, 48, 50 and 72.
1 secondary outcome
Safety Monitoring
Time frame: Through Week 49
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
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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.
Nittaya Phanuphak,, MD, PhD principal investigator
Thai Red Cross AIDS Research Centre
Jintanat Ananworanich, MD, PhD study chair
US Military HIV Research Program
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AIDSVAX B/E in people with HIV Infections, run by U.S. Army Medical Research and Development Command 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 16 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: status not confirmed, as of the sponsor's last update on 19 Sep 2019. 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 phase mean?
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?
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?
Change in Immune Response (time frame: Through Week 72). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2019.