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NCT Number: NCT01092611

Long-term Follow-up of Participants From Studies Evaluating GSK HIV Vaccine

The purpose of this long-term follow-up study is to assess the long-term health status of HIV-infected subjects who previously participated in GSK-sponsored trials evaluating the investigational HIV vaccine 732462. This study will provide additional data concerning the long-term benefits/risks associated with vaccination.

No vaccine will be administered during the study period. Vaccines were administered during the primary studies.

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Key information

Conditions

AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site, Bobigny, France

Loading trial locations.

About this study

General information on the health of the subject and persistence of the cellular and humoral immune responses to study vaccination will be evaluated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All subjects must satisfy ALL the following criteria at study entry:

  • HIV-infected subject.
  • Previous participation in a study evaluating GSK HIV vaccine 732462.
  • Written informed consent obtained from the subject.

Exclusion criteria

The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:

  • Subjects who did not receive a complete vaccination course in previous studies.

Treatment and study plan

Blood Collection

Procedure

Once a year after Visit 1 (during a maximum of 4 years). The samples will only be taken in conjunction with, and at the same time as, planned routine blood testing using the same needle-stick.

GSK HIV vaccine 732462

Biological

No vaccine will be administered during this long-term follow-up study. Vaccines were administered during the primary studies.

Primary outcomes

  1. Occurrence of Anti-Retroviral Therapy (ART) (re)-initiation or ART modification, and reason (for ART modification)

    Time frame: Once a year after Visit 1 (during a maximum of 4 years)

  2. CD4 count

    Time frame: Once a year after Visit 1 (during a maximum of 4 years)

  3. Viral load (VL) and method of measurement

    Time frame: Once a year after Visit 1 (during a maximum of 4 years)

  4. Occurrence of HIV disease progression

    Time frame: Once a year after Visit 1 (during a maximum of 4 years)

  5. Occurrence of each separate defining condition for HIV-disease progression

    Time frame: Once a year after Visit 1 (during a maximum of 4 years)

  6. Occurrence of specific clinical events and death

    Time frame: Once a year after Visit 1 (during a maximum of 4 years)

  7. Occurrence of adverse events (AEs) or serious adverse events (SAEs) considered by the Investigator to be related to vaccination (performed in the preceding vaccination study)

    Time frame: Once a year after Visit 1 (during a maximum of 4 years)

  8. Occurrence of potential immune-mediated diseases (pIMDs)

    Time frame: Once a year after Visit 1 (during a maximum of 4 years)

  9. Occurrence of SAEs related to study participation

    Time frame: Once a year after Visit 1 (during a maximum of 4 years)

Secondary outcomes

  1. Time between dose 1 and ART (re)-initiation or ART modification

    Time frame: Once a year after Visit 1 (during a maximum of 4 years)

  2. Time between dose 1 and CD4 count measurement

    Time frame: Once a year after Visit 1 (during a maximum of 4 years)

  3. Time between dose 1 and VL measurement

    Time frame: Once a year after Visit 1 (during a maximum of 4 years)

  4. Time between dose 1 and occurrence of HIV disease progression

    Time frame: Once a year after Visit 1 (during a maximum of 4 years)

  5. Time between dose 1 and occurrence of each separate defining condition for HIV-disease progression

    Time frame: Once a year after Visit 1 (during a maximum of 4 years)

  6. Antibody concentrations to vaccine antigens

    Time frame: Once a year after Visit 1 (during a maximum of 4 years)

  7. Cell-mediated immunity responses

    Time frame: Once a year after Visit 1 (during a maximum of 4 years)

  8. Additional exploratory immunogenicity endpoints (other T-cell immune markers or T-cell functional assays)

    Time frame: Once a year after Visit 1 (during a maximum of 4 years)

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Long-term Follow-up of Participants From Studies Evaluating the HIV Vaccine 732462

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Mar 25, 2010
Registry last updated
Mar 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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