Safety and Immunogenicity of Two Intradermal Rabies Vaccine Regimens Administered With and Without Human Rabies Immunoglobulin in Subjects ≥ 1 Years of Age

Novartis

Status and phase: Completed; Phase 3

Conditions: Rabies Infection

Treatments: Biological: Rabies vaccine; Biological: Rabies vaccines + Rabies immunoglobulins

Study type: Interventional

Funder types: Industry

Identifiers

NCT02177032

2013-CT0191 (Registry Identifier)

V49_30

Details and patient eligibility

About

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.

Enrollment: 885 patients

Sex: All

Ages: 1+ year old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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885 participants in 4 patient groups

4-sites, 1-week without HRIG

Experimental group

Description:

PCEC rabies vaccine, administered ID according to the "4-sites, 1-week" regimen

Treatment:

Biological: Rabies vaccine

Biological: Rabies vaccine

4-sites, 1-week with HRIG

Experimental group

Description:

PCEC rabies vaccine, administered ID to adults, according to the "4-sites, 1-week" regimen plus HRIG

Treatment:

Biological: Rabies vaccines + Rabies immunoglobulins

Biological: Rabies vaccines + Rabies immunoglobulins

2-sites, TRC without HRIG

Active Comparator group

Description:

PCEC rabies vaccine, administered ID according to the "2-sites, TRC" regimen

Treatment:

Biological: Rabies vaccine

Biological: Rabies vaccine

2-sites, TRC with HRIG

Active Comparator group

Description:

PCEC rabies vaccine, administered ID to adults , according to the "2-sites, TRC" regimen plus HRIG

Treatment:

Biological: Rabies vaccines + Rabies immunoglobulins

Biological: Rabies vaccines + Rabies immunoglobulins