Reactogenicity, Safety and Immunogenicity of a Live Monovalent A/17/California/66/395 (H2N2)Influenza Vaccine
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Influenza
- Sponsor
- PATH
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Percentage of Participants With Immediate Reactions
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This is a phase I study to evaluate the safety of a vaccine to protect against influenza viruses of the H2N2 subtype. A total of 40 adults will be enrolled and receive two doses of vaccine or placebo one month apart.
Detailed Description
The aim of this study is to evaluate the safety profile of two intranasal doses of LAIV A/17/California/66/395 (H2N2) in healthy adults in Russia. A(H2N2) viruses which are antigenically similar to the pandemic strain A/Singapore/1/57, continue to circulate in domestic and wild bird populations, as confirmed by routine moni¬toring of avian influenza viruses. 40 adults aged 18-40 will be enrolled. They will be randomized to receive vaccine or placebo. Blood and urine will be collected during the week following each vaccination and before the next vaccination to monitor safety. Blood samples will also be collected at several timepoints to assess the volunteer's immune response to the vaccine. The total duration of the study is 16 weeks for each volunteer.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Legal male or female adult aged 18 through 40 years
- •Literate and willing to provide written informed consent.
- •A signed informed consent.
- •Free of obvious health problems, as established by medical history and screening evaluations, including physical examination.
- •Capable and willing to complete diary cards and willing to return for all follow-up visits
- •Willing to comply with the rules of isolation unit (including willing and able to take oseltamivir influenza antiviral medication, should that be recommended by study physician).
- •For females, willing to take reliable birth control measures through day 56.
Exclusion Criteria
- •Participation in another clinical trial involving any therapy within the previous three months or planned enrollment in such a trial during trial period.
- •Receipt of any non-study vaccine within four weeks prior to enrollment or refusal to postpone receipt of such vaccines until four weeks after study completion.
- •Practice of nasal irrigation on a regular basis within the past six months or has engaged in nasal irrigation within two weeks prior to enrollment.
- •Recent history of frequent nose bleeds (\>5 within the past year).
- •Clinically relevant abnormal paranasal anatomy.
- •Recent history (within the past month) of rhino or sinus surgery, or surgery for any traumatic injury of the nose.
- •Current or recent (within two weeks of enrollment) acute respiratory illness with or without fever.
- •Other acute illness at the time of study enrollment.
- •Receipt of immune globulin or other blood products within three months prior to study enrollment or planned receipt during period of subject participation in the study.
- •Chronic administration (defined as more than 14 consecutively-prescribed days) of immunosuppressants and/or other immune-modulating therapy within six months prior to study enrollment.
Outcomes
Primary Outcomes
Percentage of Participants With Immediate Reactions
Time Frame: 2 hours
Measured as observed by study staff or reported by the subject to study staff whether related or not related.
Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 1
Time Frame: 7 days
Adverse events commonly associated with intranasal vaccination occurring greater than two hours after administration of any dose of study vaccine or placebo through 6 days following any dose, measured as observed by study staff or reported by the subject to study staff. Solicited local reactions included: dryness of the nose, nose bleeds, ticklish nose, nasal congestion, runny nose, ticklish throat, catarrhal nasopharynx. Solicited systemic reactions included: body temperature, feverishness/subjective fever, chills, cough, difficulty breathing, sore throat, headache, confusion, convulsions/seizures, fatigue/malaise, joint aches, muscle aches, pink or red eyes, draining eyes, swollen eyelids, ear pain or discharge, rash, abdominal pain, diarrhea, vomiting.
Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 2
Time Frame: 7 days
Adverse events commonly associated with intranasal vaccination occurring greater than two hours after administration of any dose of study vaccine or placebo through 6 days following any dose, measured as observed by study staff or reported by the subject to study staff. Solicited local reactions included: dryness of the nose, nose bleeds, ticklish nose, nasal congestion, runny nose, ticklish throat, catarrhal nasopharynx. Solicited systemic reactions included: body temperature, feverishness/subjective fever, chills, cough, difficulty breathing, sore throat, headache, confusion, convulsions/seizures, fatigue/malaise, joint aches, muscle aches, pink or red eyes, draining eyes, swollen eyelids, ear pain or discharge, rash, abdominal pain, diarrhea, vomiting.
Percentage of Subjects With Unsolicited Adverse Events After Vaccination 1
Time Frame: 7 days following each vaccination
All other adverse events (including unsolicited events and abnormal laboratory parameters) occurring during the 6 days following any dose, measured as observed by study staff or reported by the subject to study staff.
Percentage of Subjects With Unsolicited Adverse Events After Vaccination 2
Time Frame: 7 days following each vaccination
All other adverse events (including unsolicited events and abnormal laboratory parameters) occurring during the 6 days following any dose, measured as observed by study staff or reported by the subject to study staff.
Secondary Outcomes
- Percentage of Subjects With Seroconversion for Serum Immunoglobulin A Antibodies(Day 28, Day 56 and Day 112)
- Percentage of Subjects With Seroconversion for Serum Immunoglobulin G Antibodies(Day 28, Day 56 and Day 112)
- Percentage of Subjects With Seroconversion for Secretory Immunoglobulin A Antibodies From Nasal Mucosa(Day 28 and Day 56)
- Percentage of Subjects With Seroconversion for Secretory Immunoglobulin A Antibodies Detected in Saliva Specimens(Day 28 and Day 56)
- Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab(Days 0-6 and Days 28-34)
- Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibodies(Day 28, Day 56 and Day 112)
- Percentage of Subjects With Seroconversion for Serum Neutralizing Antibodies(Day 28, Day 56 and Day 112)
- Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab(Days 0-6 and Days 28-34)
- Percentage of Subjects Shedding Influenza A Virus Using Throat Swab(Days 0-6 and Days 28-34)
- Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab(Days 1-6 and Days 29-34)