| Study summary: |
|
The main purpose of this study is to test the safety of a new influenza (flu) vaccine called HAC1. This vaccine may help protect people from the H1N1 or swine flu virus. This is the first time this particular vaccine will be given to people. There is currently an approved vaccine for the H1N1 (“swine”) flu. However, there may be some drawbacks to producing the vaccine; such as number of doses or if changes to the ingredients are needed rapidly. Current technology limits the amount of vaccine that may be made, which in turn, can lead to decreased availability when needed.
The flu is a common infection caused by influenza viruses. The flu can cause mild to severe illness, with symptoms such as fever, chills, fatigue, cough, runny or stuffy nose, body aches, nausea and vomiting. Certain people at high risk, such as the very young or elderly, or those with chronic illnesses or are immunocompromised (such as those with cancer or HIV) may have serious complications, which can lead to death. Flu vaccines have been used safely and effectively to prevent, or decrease symptoms, for many years.
Last year (2009), a new and very different flu virus began spreading among people called the H1N1 flu (sometimes called the “swine flu”). This particular virus may cause either a greater number of people to become ill, or the illness may be more severe than usual. Worldwide there have been over 480,000 cases of H1N1. There is currently an approved vaccine for the H1N1 (“swine”) flu. However, there may be some drawbacks to producing the vaccine; such as number of doses or if changes to the ingredients are needed rapidly.
Group 1 - Low dose HAC1 vaccine with no adjuvant
Group 2 - Low dose HAC1 vaccine with adjuvant
Group 3 - Medium dose HAC1vaccine with no adjuvant
Group 4 - Medium dose HAC1vaccine with adjuvant
Group 5 - High dose HAC1vaccine with no adjuvant
Group 6 - High dose HAC1 vaccine with adjuvant
Group 7 - Placebo (a saline injection to compare reactions, no vaccine or adjuvant)
Group 8 - FDA approved monovalent influenza H1N1 vaccine(not the experimental vaccine this study is testing) and placebo (for 2nd injection)
This is a dose escalation study, which means we will vaccinate the low dose first followed by the medium and high dose groups. Each group will receive 2 doses of vaccine or placebo given about 21 days apart.
Follow-up visits involve a brief physical exam, collection of blood, and a review of any symptoms that occurred. The total time volunteers must be available is 10months; 3 months for screening and approximately 7 months for vaccination and follow-up.
|
| Qualified participants must: |
|
• Be 18-50 years of age
•
Be healthy
•
Not be pregnant or lactating and willing to use reliable contraception for the duration of the study
•
Cannot have received any vaccine (including seasonal influenza immunization) within the 30 days before the first dose of study vaccine, or have a high flu titer
•
Cannot have donated or received any blood products in the last 3 months or plan to receive them during the study
•
Cannot have human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus infection
•
Cannot have certain medical conditions or take certain medications
|
| Participants will receive: |
|
All study-related procedures and study vaccinations are performed at no cost. Participants will be compensated for their time. |