Investigation of the Safety of an HIV-1 Vaccine Given Intra-muscularly and Intra-nasally to Healthy Female Subjects
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ClinicalTrials.gov Identifier: NCT01084343 |
Recruitment Status
:
Completed
First Posted
: March 10, 2010
Last Update Posted
: July 13, 2012
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Condition or disease | Intervention/treatment | Phase |
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HIV-1 | Biological: MYM-V101 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
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. |
Study Start Date : | November 2009 |
Actual Primary Completion Date : | September 2010 |
Actual Study Completion Date : | September 2010 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Panel 1
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).
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Biological: MYM-V101
Other Names:
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Active Comparator: Panel 2
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).
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Biological: MYM-V101
Other Names:
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- 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.
- Humoral immune response (in blood) [ Time Frame: 24 weeks ]Quantification of blood antibodies (IgG and IgA).

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01084343
Belgium | |
CEVAC | |
Ghent, Belgium, 9000 |
Principal Investigator: | Geert Leroux-Roels, Prof. Dr. | CEVAC, University of Ghent, Belgium | |
Study Chair: | Sylvain Fleury, PhD | Mymetics Corporation |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Dr. Sylvain Fleury, Mymetics Corporation |
ClinicalTrials.gov Identifier: | NCT01084343 History of Changes |
Other Study ID Numbers: |
MYM-V101-CT08-101 2008-007306-10 ( EudraCT Number ) |
First Posted: | March 10, 2010 Key Record Dates |
Last Update Posted: | July 13, 2012 |
Last Verified: | October 2009 |
Keywords provided by Mymetics Corporation:
vaccination prophylaxis |
Additional relevant MeSH terms:
Vaccines Immunologic Factors Physiological Effects of Drugs |