HIV-1Phase 1NCT01084343
Investigation of the Safety of an HIV-1 Vaccine Given Intra-muscularly and Intra-nasally to Healthy Female Subjects
A Phase 1 study testing MYM-V101 in people with HIV-1, run by Mymetics Corporation at 1 site in Belgium.
Trial summary
This study is designed to investigate the safety and efficacy of a newly developed vaccine against HIV-1 in female healthy subjects. Safety will be assessed by local and systemic adverse reactions, investigations of blood and urine, and physical exam including vital sign measurements. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV-1
- What is being tested?
- MYM-V101
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2009to Sep 2010
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female, aged between 18 and 45 years, extremes included
- Having regular menstrual cycles (24 to 30 days). Women that got sterilized by bilateral tubal ligation are allowed, as long as they have regular cycles
- Non-smoking or smoking (no more than 10 cigarettes or 2 cigars or 2 pipes per day, for at least 3 months prior to selection)
- Body Mass Index (BMI) of 18.0 to 30.0 kg/m2, extremes included. BMI is calculated as the weight (in kg) divided by the square of height (in m)
- Informed Consent Form (ICF) signed voluntarily before first trial-related activity
- Able to comply with all protocol requirements
- Healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination, a gynecological examination, medical history, electrocardiogram, vital signs and the results of blood biochemistry and hematology tests and a urinalysis carried out at screening
- If the subject is of childbearing potential, agrees to use adequate contraception (oral contraceptives or double barrier method, as described in section 5.2.4, point 7 of the protocol) and not become pregnant for the duration of the study.
Who cannot join
- Male
- Female subject without regular menstrual cycle (24-30 days)
- History of total hysterectomy
- Female subject of childbearing potential without use of effective birth control method(s), or not willing to continue practicing these birth control method(s) for the duration of the trial
- Spermicides or other chemicals as used in contraceptive barrier methods (i.e., a male or female condom, diaphragm, cervical cap or intra-uterine device);
- A positive pregnancy test or breast feeding at screening
Show all 28Show fewer
- A positive HIV-1 or HIV-2 test at trial screening
- Having vaginitis as observed by local inspection and vaginal swab
- Recurrent vaginal infections or sexually transmitted diseases within one year prior to vaccination
- A positive test for Hepatitis A (confirmed by hepatitis A antibody IgM), hepatitis B (confirmed by hepatitis B surface antigen), or hepatitis C (confirmed by hepatitis C virus antibody) infection at trial screening
- History or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drugs which in the investigator's opinion would compromise subject safety or compliance with trial procedures
- Currently active or underlying diabetes, gastrointestinal, cardiovascular, neurological, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory, auto-immune disease(s), inheritable immune deficiency(s), infectious disease(s), nasal disorders (i.e. rhinitis, chronic nose bleeds, chronic sinusitis, polyps, chronic cold sores), dental or mouth infections, or rectal problems (fistals, hemorrhoids)
- History of allergic disease (i.e. egg, milk, dairy products) or reaction likely to be exacerbated by any component of the vaccine to be administered in this trial, and severe allergic disease(s)
- Contraindication to i.m. injections, history of bleeding disorder or use of anticoagulant therapy within 4 weeks prior to the first study vaccination
- Having received any of the following substances:
- Nasal or inhalation corticosteroids within 2 weeks prior to first vaccination
- Vaginal and/or rectal treatment within 3 days prior to first mucosal sampling
- HIV vaccine in a prior clinical trial
- Immunosuppressive medications within 6 months prior to first vaccination
- Blood products within 120 days prior to the first vaccination
- Immunoglobulin within 60 days prior to the first vaccination
- Any investigational or non-registered drug or vaccine within 30 days preceding the first vaccination
- Any planned vaccination during the study period and safety follow-up
- Allergy treatment with antigen injections, within 14 days prior to the first study vaccination
- Current anti-tuberculosis preventive therapy or treatment
- Serious adverse reactions to vaccines such as, but not limited to, anaphylaxis, urticaria (hives), respiratory difficulty, angioedema, or abdominal pain or a history of anaphylactic reactions
- Donation of blood or plasma within the 30 days preceding the first vaccination
- Acute disease at the time of enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Dose Escalating Phase I Study, Double-blind, Randomized, Placebo-controlled for Examining the Safety and Tolerability to a Prophylactic HIV-1 Vaccine Called MYM-V101, Administered i.m. in Combination With i.n. Administrations to Healthy Female Subjects.
This study is designed to investigate the safety and efficacy of a newly developed vaccine against HIV-1 in female healthy subjects. Safety will be assessed by local and systemic adverse reactions, investigations of blood and urine, and physical exam including vital sign measurements. Efficacy will be assessed in blood, and in vaginal and rectal mucosal samples.
Read the detailed description
The current treatment of HIV is aimed at delaying the disease process after the body has been infected with the virus. HIV treatment does not prevent the spreading of the virus to uninfected people. Prevention of HIV infection could be realized by a vaccine. An effective vaccine could slow down the world wide epidemic. None of the potential vaccines investigated in the past 20 years could provide protection to HIV. All these vaccines were aimed at stimulating an immune reaction in the blood. A new theory has been raised that protection against HIV should take place at the site where the virus in most cases enters the body after sexual contacts, in the vagina and rectum. Mymetics Corporation, sponsor of this clinical trial, has developed a new vaccine, based on the so-called virosome technique. This vaccine should be able to induce a local immune reaction in the mucosa of vagina and rectum. Investigations in laboratory animals showed that the newly developed vaccine was safe and well tolerated and a local immune reaction in the mucosa could be established. The next step is to investigate if the concept of mucosal immunity does also apply in the human being. Therefore this trial is being designed to investigate if the newly developed vaccine is also safe and well tolerated in healthy subjects. In addition, it will be investigated if the vaccine can induce an immune response in the mucosa of vagina and rectum. The vaccine will be investigated for the first time in man. The vaccine consists of a very small part of the HIV 1 virus, coupled to a carrier, the virosome. The vaccine also contains two proteins of the influenza virus. These are needed for stability of the vaccine and activation of the immune system in general. There will be two groups of 12 healthy female subjects. In total 24 subjects will participate in this study. The first group will be vaccinated with a low dose of the vaccine (10 microgram of peptide). If the vaccine is assessed as safe during the safety reviews, the second group will be vaccinated with a high dose of vaccine (50 microgram of peptide). Safety and tolerability of the high dose will also be assessed during two safety reviews. Each subject will be vaccinated on four occasions, separated by eight weeks. The first two vaccinations will be given in the muscles and the third and fourth vaccination will be given in the nose in order to enhance the immune response in the mucosa. In both groups, eight subjects will be vaccinated with the real vaccine and four subjects will be vaccinated with the carrier only (placebo). Nor the investigator neither the subject will know which vaccination they receive. It will be a so-called double-blinded study. Safety and tolerability will be assessed by the local and systemic adverse reactions. In addition, blood and urine will be investigated and subjects will have a physical examination including vital signs measurements. At home, subjects will complete a diary card for the registration of local and systemic adverse events. The immune response in blood will be measured. For the investigation of the mucosal immune response, a smear from the mucosa of vagina and rectum will be taken and investigated at four visits. This will be performed with special sponges and it is a painless procedure. Total duration of the study for each subject will be 32-34 weeks. HIV infection due to this vaccination is not possible.
- Conditions
- HIV-1
- Being tested
- MYM-V101
- Keywords
- vaccination, prophylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MYM-V101Biological
Also called MYM-V101.1: low dose intramuscular, MYM-V101.2: high dose intramuscular, MYM-V101.3: high dose intranasal, MYM-V101.4: low dose intranasal
- Panel 1: 2 vaccinations in the muscles followed by 2 vaccinations in the nose, 10 microgram or placebo each, every 8 weeks.
- Panel 2: 2 vaccinations in the muscles followed by 2 vaccinations in the nose, 50 microgram or placebo each, every 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Panel 1 | Active comparator | Subjects in this panel receive the low dose of vaccine (10 microgram of peptides). Twelve subjects are included in this panel, 8 of them receive the active vaccine and 4 receive the carrier only (placebo). Receives: Biological: MYM-V101 |
| Panel 2 | Active comparator | Subjects in this panel receive the high dose of vaccine (50 microgram of peptides). Twelve subjects are included in this panel, 8 of them receive the active vaccine and 4 receive the carrier only (placebo). Receives: Biological: MYM-V101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (local and systemic)
Adverse events will be collected in the CRF by the investigator. In addition, the subjects will keep a diary card in order to collect adverse events at home.
Measured: 24 weeks
Secondary outcomes (1)
Humoral immune response (in blood)
Quantification of blood antibodies (IgG and IgA).
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startNov 2009
- Primary completionSep 2010
- Study completionSep 2010
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-1Studies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mymetics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kinesis Pharma B.V., CEVAC, M.A.R.C.O., Mouton's Safety Consultancy, Pharmafour, Pevion, Chimera, Institut Cochin, San Raffaele University Hospital, Italy, INSERM UMR 721
- Investigators
- Geert Leroux-Roels, Prof. Dr., Principal investigator, CEVAC, University of Ghent, BelgiumSylvain Fleury, PhD, Study chair, Mymetics Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084343
- Sponsor's protocol ID
- MYM-V101-CT08-101
- Other IDs
- 2008-007306-10, 2008
- Status last verified
- Oct 2009
- First submitted
- 9 Mar 2010
- Last updated
- 13 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Leroux-Roels G, Maes C, Clement F, van Engelenburg F, van den Dobbelsteen M, Adler M, Amacker M, Lopalco L, Bomsel M, Chalifour A, Fleury S. Randomized Phase I: Safety, Immunogenicity and Mucosal Antiviral Activity in Young Healthy Women Vaccinated with HIV-1 Gp41 P1 Peptide on Virosomes. PLoS One. 2013;8(2):e55438. doi: 10.1371/journal.pone.0055438. Epub 2013 Feb 20.
PubMed 23437055
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Escalating Phase I Study, Double-blind, Randomized, Placebo-controlled for Examining the Safety and Tolerability to a Prophylactic HIV-1 Vaccine Called MYM-V101, Administered i.m. in Combination With i.n. Administrations to Healthy Female Subjects.
- ClinicalTrials.gov ID
- NCT01084343
- Acronym / sponsor ID
- MYM-V101-CT08-101
- Conditions
- HIV-1
- Keywords
- vaccination, prophylaxis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mymetics CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Kinesis Pharma B.V., CEVAC, M.A.R.C.O., Mouton's Safety Consultancy, Pharmafour, Pevion, Chimera, Institut Cochin, San Raffaele University Hospital, Italy, INSERM UMR 721
- Study start
- Nov 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 10 Mar 2010 (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 is designed to investigate the safety and efficacy of a newly developed vaccine against HIV-1 in female healthy subjects. Safety will be assessed by local and systemic adverse reactions, investigations of blood and urine, and physical exam including vital sign measurements. Efficacy will be assessed in blood, and in vaginal and rectal mucosal samples.
Detailed description
The current treatment of HIV is aimed at delaying the disease process after the body has been infected with the virus. HIV treatment does not prevent the spreading of the virus to uninfected people. Prevention of HIV infection could be realized by a vaccine. An effective vaccine could slow down the world wide epidemic. None of the potential vaccines investigated in the past 20 years could provide protection to HIV. All these vaccines were aimed at stimulating an immune reaction in the blood. A new theory has been raised that protection against HIV should take place at the site where the virus in most cases enters the body after sexual contacts, in the vagina and rectum. Mymetics Corporation, sponsor of this clinical trial, has developed a new vaccine, based on the so-called virosome technique. This vaccine should be able to induce a local immune reaction in the mucosa of vagina and rectum. Investigations in laboratory animals showed that the newly developed vaccine was safe and well tolerated and a local immune reaction in the mucosa could be established. The next step is to investigate if the concept of mucosal immunity does also apply in the human being. Therefore this trial is being designed to investigate if the newly developed vaccine is also safe and well tolerated in healthy subjects. In addition, it will be investigated if the vaccine can induce an immune response in the mucosa of vagina and rectum. The vaccine will be investigated for the first time in man. The vaccine consists of a very small part of the HIV 1 virus, coupled to a carrier, the virosome. The vaccine also contains two proteins of the influenza virus. These are needed for stability of the vaccine and activation of the immune system in general. There will be two groups of 12 healthy female subjects. In total 24 subjects will participate in this study. The first group will be vaccinated with a low dose of the vaccine (10 microgram of peptide). If the vaccine is assessed as safe during the safety reviews, the second group will be vaccinated with a high dose of vaccine (50 microgram of peptide). Safety and tolerability of the high dose will also be assessed during two safety reviews. Each subject will be vaccinated on four occasions, separated by eight weeks. The first two vaccinations will be given in the muscles and the third and fourth vaccination will be given in the nose in order to enhance the immune response in the mucosa. In both groups, eight subjects will be vaccinated with the real vaccine and four subjects will be vaccinated with the carrier only (placebo). Nor the investigator neither the subject will know which vaccination they receive. It will be a so-called double-blinded study. Safety and tolerability will be assessed by the local and systemic adverse reactions. In addition, blood and urine will be investigated and subjects will have a physical examination including vital signs measurements. At home, subjects will complete a diary card for the registration of local and systemic adverse events. The immune response in blood will be measured. For the investigation of the mucosal immune response, a smear from the mucosa of vagina and rectum will be taken and investigated at four visits. This will be performed with special sponges and it is a painless procedure. Total duration of the study for each subject will be 32-34 weeks. HIV infection due to this vaccination is not possible.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Panel 1 | Active comparator | Biological: MYM-V101Subjects in this panel receive the low dose of vaccine (10 microgram of peptides). Twelve subjects are included in this panel, 8 of them receive the active vaccine and 4 receive the carrier only (placebo). |
| Panel 2 | Active comparator | Biological: MYM-V101Subjects in this panel receive the high dose of vaccine (50 microgram of peptides). Twelve subjects are included in this panel, 8 of them receive the active vaccine and 4 receive the carrier only (placebo). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Female, aged between 18 and 45 years, extremes included
- Having regular menstrual cycles (24 to 30 days). Women that got sterilized by bilateral tubal ligation are allowed, as long as they have regular cycles
- Non-smoking or smoking (no more than 10 cigarettes or 2 cigars or 2 pipes per day, for at least 3 months prior to selection)
- Body Mass Index (BMI) of 18.0 to 30.0 kg/m2, extremes included. BMI is calculated as the weight (in kg) divided by the square of height (in m)
- Informed Consent Form (ICF) signed voluntarily before first trial-related activity
Key exclusion criteria (28 listed)
- Male
- Female subject without regular menstrual cycle (24-30 days)
- History of total hysterectomy
- Female subject of childbearing potential without use of effective birth control method(s), or not willing to continue practicing these birth control method(s) for the duration of the trial
- Spermicides or other chemicals as used in contraceptive barrier methods (i.e., a male or female condom, diaphragm, cervical cap or intra-uterine device);
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 |
|---|---|---|
| MYM-V101Also: MYM-V101.1: low dose intramuscular, MYM-V101.2: high dose intramuscular, MYM-V101.3: high dose intranasal, MYM-V101.4: low dose intranasal* Panel 1: 2 vaccinations in the muscles followed by 2 vaccinations in the nose, 10 microgram or placebo each, every 8 weeks. * Panel 2: 2 vaccinations in the muscles followed by 2 vaccinations in the nose, 50 microgram or placebo each, every 8 weeks. | Biological | Panel 1, Panel 2 |
Primary outcome
Adverse events (local and systemic)
Time frame: 24 weeks
Adverse events will be collected in the CRF by the investigator. In addition, the subjects will keep a diary card in order to collect adverse events at home.
1 secondary outcome
Humoral immune response (in blood)
Time frame: 24 weeks
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 13 Jul 2012.
- Derived from this study: PubMed 23437055Leroux-Roels G, Maes C, Clement F, van Engelenburg F, van den Dobbelsteen M, Adler M, Amacker M, Lopalco L, Bomsel M, Chalifour A, Fleury S. Randomized Phase I: Safety, Immunogenicity and Mucosal Antiviral Activity in Young Healthy Women Vaccinated with HIV-1 Gp41 P1 Peptide on Virosomes. PLoS One. 2013;8(2):e55438. doi: 10.1371/journal.pone.0055438. Epub 2013 Feb 20.
- Sponsor of the trialLink provided by the sponsor.
- Clinical site of the trialLink 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.
Geert Leroux-Roels, Prof. Dr. principal investigator
CEVAC, University of Ghent, Belgium
Sylvain Fleury, PhD study chair
Mymetics Corporation
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 MYM-V101 in people with HIV-1, run by Mymetics Corporation 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 8 inclusion and 28 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 13 Jul 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?
Adverse events (local and systemic) (time frame: 24 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 NCT01084343, 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 Jul 2012.