A Phase 1/2 Clinical Trial of a GamLPV, a Live Intranasal Bordetella Pertussis Vaccine

NCT04036526 | Unknown Phase 1 DMC

• 1 other identifier: GamLPV-02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The study should be leaded as a randomized double-blind placebo-controlled comparative research of potency and safety of a GamLPV, a live intranasal Bordetella pertussis vaccine, using two dosing schedules and methods of application in healthy human volunteers. The study contains three periods: screening, inpatient hospitalization and follow-up.

Conditions

Whooping Cough

Keywords

Bordetella pertussis; Live vaccine; Immunological factors; antibody response; cell immune response; whooping cough

Outcome Measures

Primary Outcomes (2)

• methods of applications

  selection of methods of applications of GamLPV, a live intranasal Bordetella pertussis vaccine (drop method or nasal actuator is important for vaccination)

  the total Time Frame is 140 days after the vaccination

• dosing schedules

  selection of dosing schedules of GamLPV, a live intranasal Bordetella pertussis vaccine (repeated administration in 60 days)

  the total Time Frame is 140 days after the vaccination

Secondary Outcomes (4)

• specific antibody response to B.pertussis

  the total Time Frame is 140 days after the vaccination

• cell immune responses to B.pertussis

  the total Time Frame is 140 days after the vaccination

• dynamics of bacteria generation in nasopharynx of human volunteers

  the total Time Frame is 140 days after the vaccination

• Comparative assessment of immunogenicity

  the total Time Frame is 140 days after the vaccination

Study Arms (2)

Group 1 Drop method

EXPERIMENTAL

Group 1 will receive vaccine/placebo by drop method.

Biological: Vaccine GamLPV; Other: Placebo

Group 2 Nasal actuator

EXPERIMENTAL

Group 2 will receive vaccine/placebo with nasal actuator.

Biological: Vaccine GamLPV; Other: Placebo

Interventions

Vaccine GamLPV BIOLOGICAL

live intranasal vaccine for whooping cough prevention

Also known as: live intranasal Bordetella pertussis vaccine

Group 1 Drop method; Group 2 Nasal actuator

Placebo OTHER

Placebo

Group 1 Drop method; Group 2 Nasal actuator

Eligibility Criteria

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

You may qualify if:

• Male or female aged 18 to 40 (inclusively);
• Healthy verified diagnosis according to standard clinical, laboratory and instrumental examination methods (no somatic disorder of the gastro-intestinal tract (GIT), liver, kidneys, cardiovascular system (CVS), infectious, hematological diseases, cancers (including if the preliminary standard clinical laboratory tests did not reveal any diseases);
• BMI froim 18 to 30 kg/m2 (inclusively);
• Consent to use of reliable birth control methods during the test period and for 3 months thereafter (a condom with spermicide);
• Signed FactSheet and Informed Consent to Participation in the Study.
• No specific IgM to the pertussis agent (negative IFA finding according to manufacturer's instruction for the anti-pertussis antibody detection test system);
• Specific anti-pertussis IgG ≤ 45 EU/ml
• No B.pertussis DNA in nasopharyngeal swabs (based on RT-PCR).

You may not qualify if:

• Whooping cough in past medical history
• Vaccination against whooping cough over the past decade
• Any other anti-infective immunization during last year
• Any medical condition (renal diseases, hepatic disorders, haematological malignancies, malignant neoplasms and other diseases) which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
• Vaccine-associated diseases or clinically significant vaccinal reactions in medical history
• Clinically significant abnormal laboratory values at the discretion of the investigator
• Positive results of HIV, hepatitis B or C
• Use of narcotic drugs and/or a history of drug/alcohol abuse
• Allergic diseases in medical history (in particular drug reaction and food allergy)
• The subject has donated blood/plasma or suffered from blood loss of at least 450 ml (1 unit of blood) within 6 weeks prior to screening
• Current participation in any other clinical trial
• Inability to adhere to the protocol
• Acute infectious diseases within 4 weeks prior to screening
• Wheezing on the results of peakflowmetry
• Significant ECG changes

Sponsors & Collaborators

• Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation: lead

Study Sites (1)

Infectious Disease Clinical Hospital No. 1 of the Moscow Healthcare Department

Moscow, Russia

RECRUITING

MeSH Terms

Conditions

Whooping Cough

Condition Hierarchy (Ancestors)

Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• Marina Rusanova

  Infectious Disease Clinical Hospital No. 1 of the Moscow Healthcare Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gennady Karataev, PhD

CONTACT

+7 499 193 61 90; karataevgi@rambler.ru

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Present clinical trial is a randomized placebo-controlled study for selection of dosing schedules and application methods of GamLPV, a live intranasal Bordetella pertussis vaccine. The study is blinded for volunteers.

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: July 29, 2019
• Study Start: June 4, 2019
• Primary Completion: May 29, 2020
• Study Completion: September 30, 2020
• Last Updated: July 31, 2019

Record last verified: 2019-07

Locations

RU (1)