A Phase 1 Dose Escalation Study to Examine the Safety of the P2-VP8 Rotavirus Vaccine
Condition: Rotavirus Infection
MeSH terms: Rotavirus Infections
Intervention: P2-VP8 subunit rotavirus vaccine; placebo
Intervention description: P2-VP8 subunit rotavirus vaccine was made by inserting a codon optimized synthetic gene for the VP8 region of rotavirus VP4 fused to the P2 T-cell epitope of tetanus toxin into the Pj411 proprietary cloning vector developed by DNA 2.0, Menlo Park, CA. The vector carries a kanamycin resistance gene as a selection marker. The vector was transfected into the BL21 strain of E. coli. The fusion protein was purified from Isopropyl β-D-1-thiogalactopyranoside (IPTG)-induced and physically lysed cultures using standard column chromatographic techniques employing Q-Sepharose and Butyl 650 as resins in addition to ultrafiltration and diafiltration.; Sodium Chloride 0.9%, USP for Injection was used to dilute the active P2-VP8 vaccine to final dosing concentration and was used for the Placebo for the study.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: rotavirus; vaccine

Summary:

      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.
    

Eligibility 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 Principal Investigator
                  (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 human immunodeficiency virus 1 (HIV-1), Hepatitis B
                  surface antigen (HBsAg) or (Hepatitis C Antibody Test) 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 Principle
                  Investigator (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