Assessment of VAC-3S Therapeutic Properties When Combined With Standard ART in the Course of HIV-1 Infection

NCT02041247 | Unknown Phase 2 DMC

• 2 other identifiers: IPROTECT12013-002735-23
• Study Type: interventional
• Target: 90
• Locations: 3 countries
• Sites: 12

Brief Summary

The purpose of this study is to evaluate the protective effect of VAC-3S in controlled HIV patients receiving standard of care antiretroviral treatment.

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• anti-3S antibodies titer

  From D0 to week 24

Secondary Outcomes (5)

• tolerance to 6 vaccinations of VAC-3S

  From D0 to week 72

• blood inflammatory marker concentrations

  From D0 to week 72

• immunogenic characteristics of VAC-3S

  From D0 to week 72

• lymphocyte phenotype markers

  From D0 to week 72

• secondary virological effects

  From D0 to week 72

Study Arms (4)

VAC-3S 16µg/administration

ACTIVE COMPARATOR

VAC-3S 16µg/ml administered every 4 weeks for 3 months followed by 3 maintenance vaccinations every 12 weeks after the third initial vaccination.

Biological: VAC-3S

VAC-3S Placebo

PLACEBO COMPARATOR

VAC-3S placebo administered every 4 weeks for 3 months followed by 3 maintenance vaccinations every 12 weeks after the third initial vaccination.

Biological: VAC-3S

VAC-3S 32 µg/administration

ACTIVE COMPARATOR

VAC-3S 32µg/ml administered every 4 weeks for 3 months followed by 3 maintenance vaccinations every 12 weeks after the third initial vaccination.

Biological: VAC-3S

VAC-3S 64 µg/administration

ACTIVE COMPARATOR

VAC-3S 64µg/ml administered every 4 weeks for 3 months without maintenance vaccination.

Biological: VAC-3S

Interventions

VAC-3S BIOLOGICAL

VAC-3S is administered via intra-muscular route in the arm.

VAC-3S 16µg/administration; VAC-3S 32 µg/administration; VAC-3S 64 µg/administration; VAC-3S Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Documented HIV-1 infection,
• Adults \> 18 and \< 60 years of age,
• Able and willing to comply with the protocol, including availability for all scheduled study visits,
• Provided a signed written informed consent,
• Meets study screening physical, medical history and laboratory assessments (defined below),
• On stable antiretroviral therapy that is consistent with the current standard of care for at least 12 months prior to study screening,
• Plasma HIV RNA \< 50 cps/mL during the previous 12 months,
• CD4+ T cell count at screening \> 200 and \< 500 cells/mm3,
• Adequate hematology, biochemistry, and metabolic blood tests defined as being less than grade 2 according to the Division of AIDS Adverse Events (See Appendix 23.1), except for the numeration of CD4 and for the numeration of lymphocytes,
• Adequate hepatic and renal function defined as being less than Grade 2 according to the Division of AIDS Adverse Events (See Appendix 23.1),
• Female patients of childbearing age with one documented negative blood pregnancy tests between Screening and Visit 1/Month 0; Female patient of childbearing potential must be receiving two forms of effective contraception and must be willing to use them throughout the study duration. These include oral, transdermal, systemic or implant contraception birth control, intra-uterine devices (IUD), abstinence and double barrier method such as diaphragm with spermicidal gel or other recommended double barrier method,
• Affiliated with the National Medical Insurance System,
• Believed by investigator to be able and willing to comply with the requirements of the study protocol and will be available for all scheduled visits at the study site.

You may not qualify if:

• Administration of any investigational drug or device within 28 days prior to screening,
• Prior history of an AIDS-defining event in the past 5 years,
• Active co-infection with either Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV) or any other active viral hepatitis co-infection,
• Any acute or clinically significant infections within the past month,
• Known allergy or intolerance to components of VAC-3S as documented through medical records or via patient interview,
• Chronic active liver disease as documented by any of the following laboratory assessments: ultrasound, clinical assessment, liver biopsy or equivalent non-invasive methods,
• Receipt of any known vaccinations within the past 1 month prior to screening,
• Receipt of any agent in the past 12 months that exerts a known immunological effect (e.g. includes but not limited to IL-2, IL-7, growth hormone…),
• Patients with Insulin Dependent Diabetes Mellitus, patients receiving anti-diabetic treatment, anticoagulants (excluding daily "baby-dose" aspirin) or daily NSAIDs within one week of study enrollment,
• Receipt of any contraindicated medications listed in Appendix 23.2,
• History of or active auto-immune disease,
• Acute or chronic psychiatric conditions which in the opinion of the investigator would need continual psychological support and/or medications incompatible with study participation,
• Patients with contraindications to intramuscular injections including, but not limited to, patients with thrombocytopenia and/or anomalies of the coagulation system,
• Any uncontrolled chronic or acute condition that in the opinion of the investigator would compromise safety of the patient or the ability to properly administer the study.

Sponsors & Collaborators

• InnaVirVax: lead

Study Sites (12)

Hôpital Sud Francilien

Corbeil-Essonne, 91106, France

Location

Hôpital de la Croix Rousse

Lyon, 69317, France

Location

Hôpital Gui de Chauliac

Montpellier, 34295, France

Location

Hôpital Saint-Antoine

Paris, 75012, France

Location

Hôpital Pitié Salpêtrière

Paris, 75013, France

Location

Hôpital Cochin Saint Vincent de Paul

Paris, 75014, France

Location

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

Hôpital Bichat - Claude Bernard

Paris, 75018, France

Location

Hôpital Tenon

Paris, 75020, France

Location

Jürgen Rockstroh

Bonn, 53105, Germany

Location

Gerd Fätkenheuer

Cologne, 63225, Germany

Location

Hospital Clinic University of Barcelona

Barcelona, 08036, Spain

Location

Study Officials

• Raphael Ho Tsong Fang, DVM PhD

  InnaVirVax

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2013
• First Posted: January 22, 2014
• Study Start: January 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: November 1, 2016
• Last Updated: June 17, 2016

Record last verified: 2016-06

Locations

DE (2); FR (9); ES (1)