Safety and Immunogenicity of Two Intradermal Rabies Vaccine Regimens Administered With and Without Human Rabies Immunoglobulin in Subjects ≥ 1 Years of Age
Condition: Rabies Infection
MeSH terms: Rabies
Intervention: Rabies vaccine; Rabies vaccines + Rabies immunoglobulins; Rabies vaccine; Rabies vaccines + Rabies immunoglobulins
Intervention description: 12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the "4-sites, 1-week" regimen (i.e. 4 doses of vaccine; in both deltoids and anterolateral thigh areas, administered on days 1, 4, and 8).; 12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen (i.e. 4 doses of vaccine; in both deltoids and anterolateral thigh areas, administered on days 1, 4, and 8). HRIG will be administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly into the gluteal muscle.; 8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the "2-sites, TRC", updated Thai Red Cross regimen (i.e. 2 doses of vaccine; in both deltoids, administered on days 1, 4, 8, and 29).; 8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen (i.e. 2 doses of vaccine; in both deltoids, administered on days 1, 4, 8, and 29). HRIG will be administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly into the gluteal muscle.
Intervention MeSH terms: Vaccines; Immunoglobulins; Immunoglobulins, Intravenous; Antibodies
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 885.0
Sex: All
Minimum age: 1 Year
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Rabies vaccines; intradermal; human rabies immunoglobulins

Summary:

      Demonstrate non-inferiority of the immune response between new versus the currently
      recommended intradermal regimens of rabies vaccine when administered with or without rabies
      immunoglobulins in healthy subjects ≥ 1 years of age.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy males and females ≥ 1 years of age

          2. Individuals/ individual's parents or legal guardians who have given written consent

          3. Individuals in good health

          4. Individuals who can comply with study procedures

        Exclusion Criteria:

          1. Behavioral or cognitive impairment or psychiatric disease.

          2. Unable to comprehend and to follow all required study procedures for the whole period
             of the study.

          3. History of illness or with an ongoing illness that may pose additional risk to the
             individual if he/she participates in the study.

          4. Individuals ≥ 1 to ≤ 17 years of age, who have or ever had a malignancy.

          5. Individuals ≥ 18 years of age, who have or who within the last 5 years, have had a
             malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder.

          6. Known or suspected impairment of the immune system (including but not limited to HIV,
             autoimmune disorders, immunosuppressive therapy as applicable).

          7. Female of childbearing potential who has not used any of the "acceptable contraceptive
             methods" for at least 2 months prior to study entry.

          8. Female of childbearing potential, refusal to use an "acceptable birth control method"
             through day 50.

          9. Female of childbearing potential, with a positive pregnancy test prior to enrollment.

         10. Received blood, blood products and/or plasma derivatives or any parenteral
             immunoglobulin preparation in the previous 12 weeks.

         11. Allergic to any of the vaccine components.

         12. Allergic to any of the human rabies immunoglobulin components.

         13. Contraindication or precaution against rabies vaccination.

         14. Contraindication or precaution against man rabies immunoglobulin administration.

         15. Planning to receive anti-malaria medications (e.g. Mefloquine) 14 days prior to day 1
             vaccination through day 50.

         16. Participating in any clinical trial with another investigational product 30 days prior
             to first study visit or intent to participate in another clinical study at any time
             during the conduct of this study.

         17. Received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for
             live vaccines) prior to enrollment in this study or who are planning to receive any
             vaccine within 28 days from the study vaccines.

         18. Body temperature ≥ 38.0°C (≥ 100.4°F) within 3 days of intended study vaccination.

         19. Received rabies vaccines or rabies immunoglobulin or have been exposed to rabies.

         20. Part of the study personnel or immediate family members of study personnel conducting
             this study.

         21. Current or history of drug or alcohol abuse within the past 2 years.