HIVPhase 1NCT01320176
Study to Evaluate the Dosage and Safety of Two Intramuscular Injections of an Investigational Clade B HIV Vaccine
A Phase 1 study testing Investigational HIV vaccine dose A and Investigational HIV vaccine dose B in people with HIV, run by Institut Pasteur at 1 site in Belgium.
Trial summary
This study aimed to evaluate the safety and reactogenicity of two intramuscular injections of two different dosages of an investigational clade B HIV vaccine. Read more about this study
- Who is it for?
- Ages 18 to 27 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Investigational HIV vaccine dose A and Investigational HIV vaccine dose B
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2010to Nov 2011
- Phase
- Phase 1
- 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 27 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) and are available for all scheduled visits at the investigational site
- Adult male and or female subjects between 18 and 27 years old.
- Proven record of measles vaccination (longer than 5 years)
- Measles antibodies titre < 350 IU/L or > 750 IU/L measured in the previous study "CEVAC sero-MV-001".
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Confirmed HIV negative based on the absence of antibodies and p24.
- Negative for Hepatitis B surface (HBs) antigen, anti-hepatitis B core (HBc antibodies) antibody and anti-Hepatitis C Virus (HCV) antibody
Who cannot join
- Participation in another clinical study in the last 6 months in which the subject has been exposed to an investigational product (pharmaceutical product or placebo or device) or concurrent participation in another clinical study during the study period.
- Previous inclusion in an HIV vaccine study.
- Receipt of any other vaccination 1 month before or planning to receive any vaccination 1 month after each study vaccination
- Receipt of tuberculin skin test 1 month before or planning to receive a tuberculin test 1 month after each study vaccination
- Receipt of allergy treatment with antigen injections 1 month before or planning to receive allergy treatment with antigen injections 1 month after each study vaccination
- Receipt of blood products or immunoglobulins within 120 days prior to enrolment.
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- Measles vaccination or booster within the last 5 years as confirmed by medical history.
- Subject is pregnant or breastfeeding or intends to become pregnant within 9 months of enrolling into the study.
- Subject is of childbearing potential and does not agree to use a medically acceptable form of contraception for the duration of the study (9 months post the first investigational HIV vaccination). Medically acceptable forms of contraception include: Contraceptive Medication, Intrauterine device, Double barrier method (Condom* and Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
- A female condom and a male condom should not be used together as friction between the two can result in either product failing.
- History of any significant immunodeficient condition.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within the 6 months prior to the first vaccination
- Individuals who are at high risk of acquired HIV infection as determined by the risk assessment questionnaire.
- Individuals who are living and/or working with severely immunocompromised people, children under 15 months old or pregnant women.
- Family history of immunodeficiency and/or personal history of autoimmune disease (including psoriasis, rheumatoid arthritis, autoimmune thyroid disease).
- History of type I or type II diabetes mellitus including cases controlled with diet alone.
- History or ongoing malignancy.
- Major congenital defects or serious chronic illness at the time of enrolment.
- History of serious adverse reactions to vaccine administration, including anaphylaxis and related symptoms, such as urticaria, respiratory difficulty, angioedema and abdominal pain to vaccines, or history of allergic reaction likely to be exacerbated by any component of the vaccine.
- Acute or chronic, clinically significant, as determined by the investigator, pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Individuals whose Body Mass index (BMI) is less than 18.5 or greater than 30 (i.e. underweight or obese).
- History of clinically significant, as determined by the investigator, neurological disorder or seizures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Phase I, Dose-escalation and Safety Study of Two Intramuscular Injections of a Dose of 2.9 Log or 4 Log CCID50 of the Recombinant HIV I Clade B Measles Vaccine Vector in Healthy Adults.
This study aimed to evaluate the safety and reactogenicity of two intramuscular injections of two different dosages of an investigational clade B HIV vaccine.
- Conditions
- HIV
- Being tested
- Investigational HIV vaccine dose A, Investigational HIV vaccine dose B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational HIV vaccine dose ABiological
The vaccine will be administered by intramuscular route into the deltoid muscle preferentially of the non dominant arm at Month 0 and Month 3
Investigational HIV vaccine dose BBiological
The vaccine will be administered by intramuscular route into the deltoid muscle preferentially of the non dominant arm at Month 0 and Month 3
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Subjects received dose A of the investigational HIV vaccine Receives: Biological: Investigational HIV vaccine dose A |
| Group B | Experimental | Subjects received dose B of the investigational HIV vaccine Receives: Biological: Investigational HIV vaccine dose B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence, intensity and relationship to vaccination of solicited local and general adverse events (AEs) except fever
Measured: 14-day follow-up after each vaccination
Occurrence, intensity and relationship to vaccination of fever
Measured: 21-day follow-up after each vaccination
Occurrence, intensity and relationship to vaccination of unsolicited adverse events (AEs)
Measured: 42-day follow-up after each vaccination
Occurrence and relationship to vaccination of any serious AEs (SAEs)
Measured: During the study period (Month 0-11)
Occurrence, intensity and relationship to vaccination of clinically significant abnormal haematology and biochemistry values (grade 3 or 4)
Measured: During the study period (Month 0-11)
Secondary outcomes (4)
Occurrence of shedding of recombinant virus
Measured: During the study period (Month 0-11)
Recombinant virus infectivity
Measured: During the study period (Month 0-11)
Cell-mediated immune response (CMI)
Measured: At day 0, 7, 14, 28, 91, 98, 112, 266
Humoral immune response to HIV antigens
Measured: At day 14, 28, 84, 98, 112, 266.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
- Study startOct 2010
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Institut PasteurThe 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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Geert - Leroux-Roels, MD, Principal investigator, Geert.lerouxRoels@UGent.be
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01320176
- Sponsor's protocol ID
- MV1-F4-CT1
- Status last verified
- Feb 2012
- First submitted
- 21 Mar 2011
- Last updated
- 14 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase I, Dose-escalation and Safety Study of Two Intramuscular Injections of a Dose of 2.9 Log or 4 Log CCID50 of the Recombinant HIV I Clade B Measles Vaccine Vector in Healthy Adults.
- ClinicalTrials.gov ID
- NCT01320176
- Acronym / sponsor ID
- MV1-F4-CT1
- Conditions
- HIV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 22 Mar 2011 (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 aimed to evaluate the safety and reactogenicity of two intramuscular injections of two different dosages of an investigational clade B HIV vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: Investigational HIV vaccine dose ASubjects received dose A of the investigational HIV vaccine |
| Group B | Experimental | Biological: Investigational HIV vaccine dose BSubjects received dose B of the investigational HIV vaccine |
Who may qualify
- Ages
- 18 to 27 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) and are available for all scheduled visits at the investigational site
- Adult male and or female subjects between 18 and 27 years old.
- Proven record of measles vaccination (longer than 5 years)
- Measles antibodies titre < 350 IU/L or > 750 IU/L measured in the previous study "CEVAC sero-MV-001".
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Key exclusion criteria (22 listed)
- Participation in another clinical study in the last 6 months in which the subject has been exposed to an investigational product (pharmaceutical product or placebo or device) or concurrent participation in another clinical study during the study period.
- Previous inclusion in an HIV vaccine study.
- Receipt of any other vaccination 1 month before or planning to receive any vaccination 1 month after each study vaccination
- Receipt of tuberculin skin test 1 month before or planning to receive a tuberculin test 1 month after each study vaccination
- Receipt of allergy treatment with antigen injections 1 month before or planning to receive allergy treatment with antigen injections 1 month after each study vaccination
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 |
|---|---|---|
| Investigational HIV vaccine dose AThe vaccine will be administered by intramuscular route into the deltoid muscle preferentially of the non dominant arm at Month 0 and Month 3 | Biological | Group A |
| Investigational HIV vaccine dose BThe vaccine will be administered by intramuscular route into the deltoid muscle preferentially of the non dominant arm at Month 0 and Month 3 | Biological | Group B |
Primary outcome
Occurrence, intensity and relationship to vaccination of solicited local and general adverse events (AEs) except fever
Time frame: 14-day follow-up after each vaccination
Occurrence, intensity and relationship to vaccination of fever
Time frame: 21-day follow-up after each vaccination
Occurrence, intensity and relationship to vaccination of unsolicited adverse events (AEs)
Time frame: 42-day follow-up after each vaccination
Occurrence and relationship to vaccination of any serious AEs (SAEs)
Time frame: During the study period (Month 0-11)
Occurrence, intensity and relationship to vaccination of clinically significant abnormal haematology and biochemistry values (grade 3 or 4)
Time frame: During the study period (Month 0-11)
4 secondary outcomes
Occurrence of shedding of recombinant virus
Time frame: During the study period (Month 0-11)
Recombinant virus infectivity
Time frame: During the study period (Month 0-11)
Cell-mediated immune response (CMI)
Time frame: At day 0, 7, 14, 28, 91, 98, 112, 266
Humoral immune response to HIV antigens
Time frame: At day 14, 28, 84, 98, 112, 266.
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 14 Feb 2012.
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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.
Geert - Leroux-Roels, MD principal investigator
Geert.lerouxRoels@UGent.be
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Investigational HIV vaccine dose A and Investigational HIV vaccine dose B in people with HIV, run by Institut Pasteur at 1 site in Belgium.
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 22 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 14 Feb 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 Belgium. 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 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.
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?
Occurrence, intensity and relationship to vaccination of solicited local and general adverse events (AEs) except fever (time frame: 14-day follow-up after each vaccination). The study lists 5 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 14 Feb 2012.