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Completed

NCT Number: NCT00316589

Safety and Immunogenicity of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in HIV Infected Patients

The purpose of this study is to gather information on the safety and immunogenicity of an investigational smallpox vaccine in HIV infected populations. Subjects will receive two vaccinations

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Research P.R., Inc., San Juan, Puerto Rico

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

  • Genders eligible for Study: Both
  • Age: between 18 and 55 years
  • Healthy volunteers are accepted

Inclusion criteria

  • Subjects tested positive for HIV-1 infection (HIV-infected subjects).
  • Subjects that are tested negative for HIV (Healthy subjects).
  • Either on stable antiretroviral therapy or not on antiretroviral therapy.
  • CD4 cells > = 200 - 750/µl.
  • Subjects must be in good general health except for HIV infection.
  • Women must not be pregnant and use an acceptable method of contraception.

Exclusion criteria

  • Impairment of immunologic function (other than HIV infection).
  • History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure.
  • Uncontrolled serious infection.
  • History of or active autoimmune disease.
  • History or clinical manifestation of clinically significant and severe hematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders.
  • History of an immediate family member (father, mother, brother, or sister) who has had onset of ischemic heart disease before the age of 50 years.
  • High risk of developing a myocardial infarction or coronary death.
  • History of intravenous drug abuse (within the last 12 months).
  • Known allergy to egg or aminoglycoside (gentamicin).
  • History of anaphylaxis or severe allergic reaction.
  • Subjects undergoing treatment for tuberculosis infection or disease.
  • Chronic administration of systemic immuno-suppressants.

Treatment and study plan

IMVAMUNE (MVA-BN)

Biological

2 immunizations, four weeks apart: 1 x 10E8 TCID50, subcutaneous

Other names: IMVANEX

Primary outcomes

  1. Serious Adverse Events

    Time frame: within 32 weeks

    Incidence, relationship and intensity of any Serious Adverse Event (SAE)

Secondary outcomes

  1. Related Grade >=3 Adverse Events

    Time frame: within 29 days after any vaccination

    Incidence of any Grade 3 or higher adverse drug reaction (missing, unknown, not evaluable, possibly, probably, or definitely related) to the study vaccine

  2. Solicited Local Adverse Events

    Time frame: within 8 days after any vaccination

    Incidence and intensity of solicited local AEs (pain, erythema, swelling). Percentages based on subjects with at least one completed diary card.

  3. Solicited General Adverse Events

    Time frame: within 8 days after any vaccination

    Incidence of solicited general AEs (increased body temperature, headache, myalgia, chills, nausea, and fatigue): Intensity and relationship to vaccination. Percentages based on subjects with at least one completed diary card.

  4. Unsolicited Adverse Events: Incidence

    Time frame: within 29 days after any vaccination

    Incidence of any unsolicited adverse events

  5. Unsolicited Adverse Events: Intensity

    Time frame: within 29 days after any vaccination

    Occurrence of unsolicited adverse events by Intensity

  6. Unsolicited Adverse Events: Relationship to Vaccination

    Time frame: within 29 days after any vaccination

    Occurrence of unsolicited adverse events by relationship to study vaccine

  7. CD4+ T-cell Counts

    Time frame: within 32 weeks

    Median CD4+ T-cell counts over time

  8. CD8+ T-cell Counts

    Time frame: within 32 weeks

    Median CD8+ T-cell counts over time

  9. Viral Load

    Time frame: within 32 weeks

    Viral load (HIV-1 RNA levels) over time

  10. PRNT Seroconversion Rate

    Time frame: within 32 weeks

    Seroconversion rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (6) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.

  11. PRNT GMT

    Time frame: within 32 weeks

    Geometric Mean Titers (GMT) based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Titers below the detection limit are included with a value of '1'.

  12. ELISA Seroconversion Rate

    Time frame: within 32 weeks

    Seroconversion rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.

  13. ELISA GMT

    Time frame: within 32 weeks

    Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Titers below the detection limit are included with a value of '1'.

  14. ELISPOT IFN-γ: Response Rate

    Time frame: within 32 weeks

    Response rate based on number of subjects with response in an interferon gamma (IFN-γ) ELISPOT assay. Response is defined as the appearance of a signal in subjects that had no signal at Baseline or a relative increase by a factor of ≥1.7 compared to Baseline in subjects that had a signal at Baseline. Percentages based on number of subjects with data available.

  15. ELISPOT IFN-γ: SFU

    Time frame: within 32 weeks

    Median number of interferon gamma (IFN-γ) secreting peripheral blood mononuclear cells (PBMC) in response to stimulation with MVA-BN detected by ELISPOT assay.

Sponsors and collaborators

Lead sponsor

Bavarian Nordic

Industry

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

A Multicenter, Open-label, Controlled Phase II Study to Evaluate Safety and Immunogenicity of MVA-BN® (IMVAMUNE) Smallpox Vaccine in 18-55 Year Old Naive and Previously Vaccinated HIV Infected Subjects With CD4 Counts >200 - 750/µl.

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Apr 21, 2006
Registry last updated
Jan 3, 2019

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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