A Phase 1 Dose Escalation Study to Examine the Safety of the P2-VP8 Rotavirus Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PATH
ClinicalTrials.gov Identifier:
NCT01764256
First received: January 7, 2013
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

This study will evaluate 3 doses of a new vaccine for rotavirus infection in healthy adult volunteers to determine if it is safe and if the immune systems of healthy adults respond to this vaccine.


Condition Intervention Phase
Rotavirus
Biological: P2-VP8 subunit rotavirus vaccine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 1 Double Blinded, Randomized, Placebo-controlled Dose Escalation Study to Examine the Safety, Reactogenicity, Tolerability and Immunogenicity of the P2-VP8 Subunit Rotavirus Vaccine in Healthy Adult Volunteers

Further study details as provided by PATH:

Primary Outcome Measures:
  • safety [ Time Frame: day 84 ] [ Designated as safety issue: Yes ]
    occurrence of Serious Adverse Events


Secondary Outcome Measures:
  • immunogenicity [ Time Frame: 4 weeks post 3rd immunization ] [ Designated as safety issue: No ]
    proportion of patients with anti-P2-VP8 IgA and IgG seroresponse


Estimated Enrollment: 48
Study Start Date: December 2012
Study Completion Date: September 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: P2-VP8 subunit rotavirus vaccine Biological: P2-VP8 subunit rotavirus vaccine
Placebo Comparator: Placebo group
12 subjects receiving 3 intramuscular injections of placebo 4 weeks apart

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A qualified volunteer must be:

    1. Healthy male or female between 18 and 45 (inclusive) years of age at time of enrollment.
    2. Willing and able to give informed consent - must pass test of comprehension with > 70% correct within two attempts.
    3. If female and of childbearing potential, be not breastfeeding and not pregnant (based on a negative serum pregnancy test at screening and a negative urine pregnancy test during the 24 hours prior to first injection), planning to avoid pregnancy for at least 4 weeks after the last injection, and willing to use an adequate method of contraception consistently and have repeated pregnancy tests prior to second and third injections.
    4. Willing to comply with study restrictions and study schedule (as evidenced by a signed informed consent form [ICF] and assessment by the PI or designee).
    5. Able and willing to be contacted by telephone or text, and willing for study staff to record telephone voice or text messages as needed.

      Exclusion Criteria:

  • A qualified volunteer must not:

    1. Have received an investigational product during the 30 days prior to randomization.
    2. Intend to receive another investigational product during this study.
    3. Have any contraindication to parenteral injections (e.g., history of bleeding disorder).
    4. Have previously received a marketed or investigational rotavirus vaccine.
    5. Have a history of severe local or systemic reaction to any vaccine.
    6. Have a history of recurrent urticaria of unknown cause.
    7. Have a history of any allergic or infusion reaction that was severe (e.g., anaphylactic or anaphylactoid), generalized (e.g., drug rash, urticaria, angioedema) or that, in the opinion of the PI, significantly increases risk of severe local or systemic reaction to an investigative vaccine.
    8. Have a history of reaction to any vaccine that, in the opinion of the PI, significantly increases risk of severe reaction to an investigative vaccine.
    9. Have received any vaccine within 4 weeks prior to randomization or planned vaccination through Day 84.
    10. Have received any blood product or any immunomodulating agent (e.g., immunoglobulin, interferon, growth factor) within 12 weeks prior to randomization.
    11. Have received immunosuppressive medications (e.g., prolonged use of systemic corticosteroid or cytotoxic agent) within the 24 weeks prior to randomization. Eligible if a short course (≤10 days) of systemic corticosteroid concluded more than 2 weeks prior to randomization, use of inhaled corticosteroid for asthma, and use of topical corticosteroid for a skin condition.
    12. Have a history of any clinically significant (in the opinion of the PI) immunosuppressive or autoimmune condition.
    13. Anticipate need for administration of any blood product, immunosuppressive (e.g., systemic corticosteroid), or immunomodulatory treatment during the study.
    14. Have a history of malignancy, excluding basal cell carcinoma.
    15. Have Diabetes Mellitus Type I or II.
    16. Have a positive test for HIV-1, HBsAg or anti-HepC.
    17. Have significant abnormalities in screening laboratory test results or clinical assessment as determined by the PI or by the PI in consultation with the Sponsor's medical officer.*
    18. Have abnormal vital signs deemed clinically relevant by the PI.*
    19. Evidence of current or recent (within past 12 months) excessive alcohol consumption or drug dependence.
    20. Have any condition of hand, arm or related lymph nodes that may confound post-dose assessments.
    21. Have any condition (medical, psychiatric or behavioral) that, in the opinion of the PI, would increase the volunteer's health risks in study participation or would increase the risk of not achieving the study's objectives
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01764256

Locations
United States, Maryland
Center for Immunization Research
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
PATH
Investigators
Principal Investigator: Clayton Harro, MD Johns Hopkins Bloomberg School of Hygiene and Public Health
  More Information

No publications provided

Responsible Party: PATH
ClinicalTrials.gov Identifier: NCT01764256     History of Changes
Other Study ID Numbers: VAC 009
Study First Received: January 7, 2013
Last Updated: October 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by PATH:
rotavirus
vaccine

ClinicalTrials.gov processed this record on September 18, 2014