Safety Trial of Monovalent Whole Virus Influenza (H1N1) Vaccine

NCT01507779 | Completed Phase 1 Results

• 1 other identifier: IVAC-mH1N1-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The study hypothesis is that two 0.5 ml doses of non-adjuvanted whole virion monovalent A/H1N1 influenza vaccine (IVACFLU)--each dose with an HA content of 15 mcg from A/California/07/2009 (H1N1)-like virus--will be safe and immunogenic in healthy adults.

Conditions

Influenza

Outcome Measures

Primary Outcomes (5)

• Number of Participants With Maximum Systemic Reaction After Vaccination 1

  Systemic and local reactogenicity data were collected on Study Days 0, 7, 21 and 28, prevaccination, and within 60 minutes post-vaccination by clinic staff. Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Solicited systemic reactogenicity events included body temperature, feverishness, chills, cough, difficulty breathing, runny nose, nasal congestion, sore throat, hoarseness of voice, headache, confusion, convulsions/seizures, fatigue/malaise, muscle aches, joint pain, pink or red eyes, sore eyes, itchy eyes, drainage from eyes, ear pain or discharge, rash, abdominal pain, diarrhea, vomiting and jaundice. Solicited local reactogenicity included size of redness, size of swelling, size of induration, pain, and tenderness.

  7 days

• Number of Participants With Maximum Systemic Reaction After Vaccination 2

  Systemic and local reactogenicity data were collected on Study Days 0, 7, 21 and 28, prevaccination, and within 60 minutes post-vaccination by clinic staff. Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Solicited systemic reactogenicity events included body temperature, feverishness, chills, cough, difficulty breathing, runny nose, nasal congestion, sore throat, hoarseness of voice, headache, confusion, convulsions/seizures, fatigue/malaise, muscle aches, joint pain, pink or red eyes, sore eyes, itchy eyes, drainage from eyes, ear pain or discharge, rash, abdominal pain, diarrhea, vomiting and jaundice. Solicited local reactogenicity included size of redness, size of swelling, size of induration, pain, and tenderness.

  7 days

• Number of Participants With Maximum Local Reaction After Vaccination 1

  Systemic and local reactogenicity data were collected on Study Days 0, 7, 21 and 28, prevaccination, and within 60 minutes post-vaccination by clinic staff. Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Solicited local reactogenicity included size of redness, size of swelling, size of induration, pain, and tenderness.

  7 days

• Number of Participants With Maximum Local Reaction After Vaccination 2

  Systemic and local reactogenicity data were collected on Study Days 0, 7, 21 and 28, prevaccination, and within 60 minutes post-vaccination by clinic staff. Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Solicited local reactogenicity included size of redness, size of swelling, size of induration, pain, and tenderness.

  7 days

• Unsolicited, Non-serious Adverse Events

  Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Adverse events were collected throughout the study period, and were graded for severity; however unsolicited adverse events were assessed only for relationship to vaccine if the events were immediate reactions or considered to be serious adverse events.

  7 days after each dose (Day 7 and Day 28)

Secondary Outcomes (12)

• Geometric Mean Titer of Hemagglutination-inhibition Antibodies (HAI)

  Day 0, Day 21 and Day 42

• Ratio of Geometric Mean Titer of Hemagglutination-inhibition Antibodies (HAI)

  Day 0, Day 21 and Day 42

• Number and Percentage of All Subjects Achieving a Four-fold Rise in Hemagglutination-inhibition Antibodies (HAI)

  Day 21 and Day 42

• Number and Percentage of Subjects Achieving a Four-fold Rise in Hemagglutination-inhibition Antibodies (HAI) Among Subjects With Baseline Titer Less Than 40

  Day 21 and Day 42

• Number and Percentage of Subjects Achieving a Four-fold Rise in Hemagglutination-inhibition Antibodies (HAI) Among Subjects With Baseline Titer Greater Than 40

  Day 21 and Day 42

Study Arms (2)

Influenza vaccine

EXPERIMENTAL

Received 0.50 mL of inactivated monovalent influenza vaccine (IVACFLU), administered intramuscularly, on days 0 and 21

Biological: IVACFLU

Placebo

PLACEBO COMPARATOR

Received placebo, administered intramuscularly, on days 0 and 21

Other: Placebo

Interventions

IVACFLU BIOLOGICAL

IVACFLU is a whole virus vaccine, collected in a linear sucrose density gradient solution using a continuous flow centrifuge Alfpa Wassmann and inactivated with formaldehyde. It was formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009(H1N1)-like virus per 0.5 mL dose and filled in single dose vials.

Also known as: whole virion monovalent A/H1N1 influenza vaccine

Influenza vaccine

Placebo OTHER

Phosphate buffered saline (PBS), pH 7.2, in 0.5 ml single-dose vials.

Placebo

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female adult 18 (age of legal consent in Vietnam) through 40 years of age at the enrollment visit.
• Literate and willing to provide written informed consent.
• Free of obvious health problems, as established by the medical history and screening evaluations, including physical examination.
• Capable and willing to complete diary cards and willing to return for all follow-up visits
• For females, willing to utilize reliable birth control measures (intrauterine device, birth control pills, condoms) through the Day 42 visit.

You may not qualify if:

• Participation in another clinical trial involving any therapy within the previous three months or planned enrollment in such a trial during the period of this study.
• Receipt of any non-study vaccine within four weeks prior to enrollment or refusal to postpone receipt of such vaccines until after the Day 42 visit.
• Current or recent (within two weeks of enrollment) acute illness with or without fever.
• Receipt of immune globulin or other blood products within three months prior to study enrollment or planned receipt of such products prior to the Day 42 visit.
• Chronic administration (defined as more than 14 consecutively-prescribed days) of immunosuppressants or other immune-modulating therapy within six months prior to study enrollment. (For corticosteroids, this means prednisone or equivalent, \>=0.5 mg per kg per day; topical steroids are allowed.)
• History of asthma.
• Hypersensitivity after previous administration of any vaccine.
• Other AE following immunization, at least possibly related to previous receipt of any vaccine.
• Suspected or known hypersensitivity to any of the study vaccine components, including chicken or egg protein.
• Known hypersensitivities (allergies) to food or the natural environment.
• Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, metabolic, neurologic, psychiatric or renal functional abnormality, as determined by medical history, physical examination or clinical laboratory screening tests, which in the opinion of the investigator, might interfere with the study objectives..
• History of leukemia or any other blood or solid organ cancer.
• History of thrombocytopenic purpura or known bleeding disorder.
• History of seizures.
• Known or suspected immunosuppressed or immunodeficient condition of any kind, including HIV infection.

Sponsors & Collaborators

• PATH: lead
• Institute of Vaccines and Medical Biologicals, Vietnam: collaborator
• Pasteur Institute, Ho Chi Minh City: collaborator

Study Sites (1)

Ben Luc Health Center

Bến Lức, Long An, Vietnam

Location

Related Publications (1)

• Thang HV, Huong VM, Victor JC, Van CB, Nga NT, Be LV, Cuong NP, Tsvetnitsky V, Neuzil KM, Power M, Flores J. Safety and immunogenicity of inactivated monovalent influenza A/H1N1 vaccine candidate manufactured in Vietnam. Vaccine. 2018 Nov 12;36(46):6918-6925. doi: 10.1016/j.vaccine.2018.10.013. Epub 2018 Oct 15.

  PMID: 30337172 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Jorge Flores
• Organization: PATH

jeflores@path.org

(202) 822-0033

Study Officials

• Kathleen M Neuzil, MD, MPH

  PATH

  STUDY DIRECTOR

• Le V Be, MD, PhD

  Institute of Vaccines and Medical Biologicals, Vietnam

  STUDY DIRECTOR

• Ho V Thang, MD, MSc

  Pasteur Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2012
• First Posted: January 11, 2012
• Study Start: April 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 27, 2019
• Results First Posted: February 27, 2019

Record last verified: 2019-02

Locations

VN (1)