Investigation of the Safety of an HIV-1 Vaccine Given Intra-muscularly and Intra-nasally to Healthy Female Subjects

NCT01084343 | Completed Phase 1

• 2 other identifiers: MYM-V101-CT08-1012008-007306-10
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. Efficacy will be assessed in blood, and in vaginal and rectal mucosal samples.

Conditions

HIV-1

Keywords

vaccination; prophylaxis

Outcome Measures

Primary Outcomes (1)

• 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.

  24 weeks

Secondary Outcomes (1)

• Humoral immune response (in blood)

  24 weeks

Study Arms (2)

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).

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).

Biological: MYM-V101

Interventions

MYM-V101 BIOLOGICAL

* 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.

Also known as: 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; Panel 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Having received any of the following substances:

Sponsors & Collaborators

• Mymetics Corporation: lead
• Kinesis Pharma B.V.: collaborator
• CEVAC: collaborator
• M.A.R.C.O.: collaborator
• Mouton's Safety Consultancy: collaborator
• Pharmafour: collaborator
• Pevion: collaborator
• Chimera: collaborator
• Institut Cochin: collaborator
• San Raffaele University Hospital, Italy: collaborator
• INSERM UMR 721: collaborator

Study Sites (1)

CEVAC

Ghent, 9000, Belgium

Location

Related Publications (1)

• 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.

  PMID: 23437055 DERIVED

Related Links

• Sponsor of the trial
• Clinical site of the trial

MeSH Terms

Interventions

Injections, Intramuscular

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Geert Leroux-Roels, Prof. Dr.

  CEVAC, University of Ghent, Belgium

  PRINCIPAL INVESTIGATOR

• Sylvain Fleury, PhD

  Mymetics Corporation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 9, 2010
• First Posted: March 10, 2010
• Study Start: November 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: July 13, 2012

Record last verified: 2009-10

Locations

BE (1)