RNActive® Rabies Vaccine (CV7201) in Healthy Adults

NCT02241135 | Completed Phase 1 DMC

• 2 other identifiers: CV-7201-1022013-002171-17
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to assess the safety and immunogenicity of an investigational RNActive® rabies vaccine (CV7201) in healthy adults.

Conditions

Rabies

Keywords

Rav G protein; rabies; VNT; immunogenicity; PrEP vaccination; mRNA; CV7201

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of serious adverse events (SAEs)/adverse events (AEs) and local tolerability assessment of the vaccination site

  The occurrence of AEs will be assessed by non-directive questioning of the subject at each visit. Further, AEs volunteered by the subject during or between visits - as subject diary card entries - or detected through observation, physical examination, laboratory test, or other assessments during the entire observation period, will be documented. Subjects will be instructed that they must immediately report any AEs, subjective complaints or objective changes in their well-being to the Investigator or the clinic personnel, regardless of the perceived relationship between the event and the test product. The Investigator is responsible for reporting all AEs in the eCRF that are observed or described by the subject, regardless of their relationship to the trial vaccine or their clinical significance.

  up to 64 days after the last vaccination

Secondary Outcomes (2)

• The lowest CV7201 dose to elicit rabies VNTs ≥ 0.5 IE/ml

  Rabies VNTs measured 14 days after the 3rd vaccination (Visit 8)

• Number of treatment discontinuation due to IMP-related AEs/SAEs

  up to 64 days after the last vaccination

Study Arms (8)

80 µg CV7201 mRNA short

EXPERIMENTAL

Vaccination by injection on days 0, 7, 28.

Biological: CV7201 mRNA

160µg CV7201 mRNA short

EXPERIMENTAL

Vaccination by injection on days 0, 7, 28.

Biological: CV7201 mRNA

80 µg CV7201 mRNA long

EXPERIMENTAL

Vaccination by injection on days 0, 28, 56.

Biological: CV7201 mRNA

160 µg CV7201 mRNA long

EXPERIMENTAL

Vaccination by injection on days 0, 28, 56.

Biological: CV7201 mRNA

320 µg CV7201 mRNA long

EXPERIMENTAL

Vaccination by injection on days 0, 28, 56.

Biological: CV7201 mRNA

640 µg CV7201 mRNA long

EXPERIMENTAL

Vaccination by injection on days 0, 28.

Biological: CV7201 mRNA

200 µg CV7201 mRNA long

EXPERIMENTAL

Vaccination by injection on days 0, 28, 56.

Biological: CV7201 mRNA

400 µg CV7201 mRNA long

EXPERIMENTAL

Vaccination by injection on days 0, 28, 56.

Biological: CV7201 mRNA

Interventions

CV7201 mRNA BIOLOGICAL

CV7201 is composed of 1 RNActive® mRNA that encodes the rabies virus glycoprotein.

Also known as: CV7201 messenger RNA, CV7201 RNActive®

160 µg CV7201 mRNA long; 160µg CV7201 mRNA short; 200 µg CV7201 mRNA long; 320 µg CV7201 mRNA long; 400 µg CV7201 mRNA long; 640 µg CV7201 mRNA long; 80 µg CV7201 mRNA long; 80 µg CV7201 mRNA short

Eligibility Criteria

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

You may qualify if:

• Healthy male and female volunteers aged 18 to 40 years inclusive
• Compliant with protocol procedures and available for clinical follow-up through the last planned visit (V9)
• Physical examination and laboratory results without clinically significant findings
• Body Mass Index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2
• Females: Negative human chorionic gonadotropin (HCG) pregnancy test (serum) for women presumed to be of reproductive potential on the day of enrolment
• Females of childbearing potential must use acceptable methods of birth control during the trial and Follow-up period (from 6 weeks before the first administration of the test vaccine for the duration of the trial i.e., until the last planned visit (V9)). The following methods of birth control are acceptable when used consistently and correctly: established use of oral, injected or implanted hormonal methods of contraception; intrauterine devices (IUDs) or intrauterine systems (IUSs) with the exception of steel or copper wire; barrier methods of contraception (condom or occlusive cap \[diaphragm or cervical/vault caps\] with spermicidal foam/gel/film/cream/suppository); true abstinence (periodic abstinence \[e.g., calendar, ovulation, symptothermal and postovulation methods\] and withdrawal are not acceptable).
• Males must use reliable forms of contraception (barrier method with spermicidal agent or true abstinence) and must refrain from sperm donation during the trial and Follow-up period i.e., until the last planned visit (V9).

You may not qualify if:

• Use of any investigational or non-registered product (drug or vaccine) other than the trial vaccine within 4 weeks preceding the administration of the trial vaccine, or planned use during the trial period
• Subject has received any other licensed vaccines within 4 weeks prior to the administration of the trial vaccine
• Subject has received any investigational or licensed rabies vaccine previously
• Intending to travel to regions/countries for which rabies vaccinations are recommended or where high risk of infections exists according to travel recommendations by the German Society of Tropical Medicine and International Health (DTG) during the trial and up to V9 (Day 91/120) Follow-up
• Any treatment with immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the trial 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 immunodeficient condition based on medical history and physical examination
• History of autoimmune disease
• Administration of immunoglobulins (Igs) and/or any blood products within the 3 months preceding the administration of the trial vaccine
• Subject is taking chloroquine for malaria treatment or prophylaxis
• Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness or fever ≥ 38 °C measured orally
• Presence or evidence of significant acute or chronic, 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 of the trial product i.e., protamine. This includes subjects with allergy to fish protein, diabetics with allergy to protamine-containing insulin, or post-vasectomy males
• Known type I allergy to beta lactam antibiotics
• Evidence of current alcohol or drug abuse

Sponsors & Collaborators

• CureVac: lead

Study Sites (1)

Abteilung für Infektions- und Tropenmedizin der Ludwig-Maximilians-Universität

Munich, 80802, Germany

Location

Related Publications (1)

• Alberer M, Gnad-Vogt U, Hong HS, Mehr KT, Backert L, Finak G, Gottardo R, Bica MA, Garofano A, Koch SD, Fotin-Mleczek M, Hoerr I, Clemens R, von Sonnenburg F. Safety and immunogenicity of a mRNA rabies vaccine in healthy adults: an open-label, non-randomised, prospective, first-in-human phase 1 clinical trial. Lancet. 2017 Sep 23;390(10101):1511-1520. doi: 10.1016/S0140-6736(17)31665-3. Epub 2017 Jul 25.

  PMID: 28754494 DERIVED

MeSH Terms

Conditions

Rabies

Condition Hierarchy (Ancestors)

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

Study Officials

• Franz-Josef Falkner von Sonnenburg, MD

  Ludwig-Maximilians - University of Munich

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 22, 2014
• First Posted: September 16, 2014
• Study Start: October 1, 2013
• Primary Completion: February 8, 2018
• Study Completion: February 8, 2018
• Last Updated: October 29, 2018

Record last verified: 2018-05

Locations

DE (1)