Safety and Tolerability of CV8102 Alone and in Combination With a Rabies Virus Vaccine in Healthy Adults

NCT02238756 | Completed Phase 1 DMC

• 2 other identifiers: CV-8102-2012013-004514-18
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to investigate the safety and tolerability of IM administered CV8102 and an IM administered combination of CV8102 and rabies vaccine in humans.

Conditions

Rabies

Outcome Measures

Primary Outcomes (1)

• Number of subjects with serious and non serious adverse events

  Up to 12 months

Secondary Outcomes (4)

• Maximum tolerated dose (MTD) of CV8102 within the dose range of 25 µg to 250 µg.

  Up to day 49

• MTD of CV8102 in combination with rabies vaccine

  Up to Day 49

• Vaccination-elicited serum rabies VNTs among the dose groups

  Up to day 35

• Vaccination-elicited innate and adaptive immune responses

  Up to Day 35

Study Arms (3)

CV8102

EXPERIMENTAL

Biological: CV8102

Rabipur

ACTIVE COMPARATOR

Biological: Rabipur

CV8102 + Rabipur

EXPERIMENTAL

Biological: CV8102 + Rabipur

Interventions

CV8102 BIOLOGICAL

Subjects will receive 2 intramuscular doses of CV8102 given 21 days apart

CV8102

Rabipur BIOLOGICAL

Subjects will receive 2 intramuscular doses of Rabipur given 21 days apart

Rabipur

CV8102 + Rabipur BIOLOGICAL

Subjects will receive 2 intramuscular doses of CV8102+Rabipur given 21 days apart

CV8102 + Rabipur

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Compliant with protocol procedures and available for clinical F/U until the protocol-defined end of the trial
• Physical examination and laboratory results without clinically significant findings
• Body Mass Index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2
• Subjects must use reliable forms of contraception (barrier method with spermicidal agent or true abstinence) and must refrain from sperm donation during treatment and the 4-week F/U period after the last treatment.

You may not qualify if:

• Use of any investigational or non-registered product (adjuvant, drug) other than CV8102 within 4 weeks preceding the administration of the CV8102, or planned use of any such agent during the trial period
• Subject has received any licensed or non-licensed vaccines within 4 weeks prior to the administration of CV8102 alone or in combination with the licensed rabies vaccine or planned vaccinations during the trial period
• Any treatment with immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of CV8102 alone or in combination with the licensed rabies vaccine. The use of inhaled and nasal steroids, as well as topical steroids outside the vaccination area, will be permitted
• Any medically diagnosed or suspected immune deficient condition based on medical history and physical examination
• History of autoimmune disease or suspected autoimmune disease based on medical history and physical examination that cannot be ruled out based on further examinations
• Administration of immunoglobulins (Igs) and/or any blood products within the 3 months preceding the administration of CV8102 or licensed rabies vaccine
• Acute disease at the time of enrolment. Acute disease is defined as the presence of any acute condition including but not limited to non-febrile or febrile common colds, urinary tract infections, inflammatory, allergic or traumatic conditions that may interfere with safety assessment of the investigational products
• Presence or evidence of significant acute or chronic disease, in particular heart disease including coronary artery disease and chronic pulmonary diseases (e.g., chronic obstructive pulmonary disease \[COPD\]); uncontrolled medical or psychiatric illness (subjects with uncomplicated chronic diagnoses stable and treated for ≥ 3 months e.g., mild hypertension well-controlled with medication, may be enrolled - provided the condition and its therapy are known not to be associated with an immunocompromised state or an autoimmune disease)
• Major congenital defects
• Known allergy to any component (or closely related substance) of the licensed rabies vaccine product
• Known type I allergy to beta-lactam antibiotics
• Evidence of current alcohol or drug abuse
• History of any neurological disorders or seizures
• Known seropositivity for human immunodeficiency virus (HIV), hepatitis B virus (HBV) (except in subjects previously vaccinated against HBV) or hepatitis C virus (HCV)
• Foreseeable non-compliance with protocol as judged by the Investigator

Sponsors & Collaborators

• CureVac: lead

Study Sites (1)

CRS Clinical Research Services Mönchengladbach GmbH

Mönchengladbach, Germany

Location

MeSH Terms

Conditions

Rabies

Condition Hierarchy (Ancestors)

Rhabdoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Ingo Meyer, MD

  CRS Clinical Research Services Mönchengladbach GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2014
• First Posted: September 12, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: November 1, 2016
• Last Updated: June 6, 2018

Record last verified: 2018-06

Locations

DE (1)