Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Low dose HB-101 · 1 trial · 1 indication
Local solicited symptoms will be assessed by diary card and scripted questions for 7 days after each administration: administration site pain, induration, erythema, pruritus and swelling
General solicited symptoms will be assessed by diary card and scripted questions for 7 days after each administration: malaise, fatigue, body temperature (measured axillary), generalized myalgia.
Unsolicited AEs will be recorded through open-ended general inquiries
SAEs and pregnancies will be recorded during the whole study
Vital signs (blood pressure, heart rate and body temperature)
general evaluation based on the Investigator judgment and local evaluation of the administration site
Complete blood count
Comprehensive Metabolic Panel
| Arm | Type | Description |
|---|---|---|
| Low dose HB-101 group | ACTIVE_COMPARATOR | Intervention:Three administrations of a low dose of HB-101 |
| Medium dose HB-101 group | ACTIVE_COMPARATOR | Intervention:Three administrations of a middle dose of HB-101. |
| High dose HB101 group | ACTIVE_COMPARATOR | Intervention:Three administrations of a high dose of HB-101. |
| Placebo group | PLACEBO_COMPARATOR | Intervention:Three administrations of placebo (diluent) |
| Name | Type | Description |
|---|---|---|
| Low dose HB-101 | BIOLOGICAL | Three intra muscular administrations at Day 0, Month 1 and Month 3 |
| Medium dose HB-101 | BIOLOGICAL | Three intra muscular administrations at Day 0, Month 1 and Month 3 |
| High dose HB-101 | BIOLOGICAL | Three intra muscular administrations at Day 0, Month 1 and Month 3 |
| Placebo | BIOLOGICAL | Three intra muscular administrations at Day 0, Month 1 and Month 3. The diluent is used as placebo. |
Inclusion Criteria: * Signed informed consent * Male or female, aged 18-45 years, in good health. * Negative for HCMV * Body mass index between 19 and 32 kg/m² * Willing to forego receipt of other routine vaccinations (with the exception of seasonal influenza vaccination) for five months after stud...
HB-101 vaccine is an investigational vaccine being developed for cytomegalovirus (CMV) infection. It is being studied in kidney transplant patients to evaluate its safety and immunogenicity. The vaccine is designed to prevent or reduce CMV infection, which can cause serious complications in immunocompromised individuals such as transplant recipients.
HB-101 vaccine is being developed by HOOKIPA Pharma Inc., a biopharmaceutical company. The company is listed on the stock exchange under the ticker symbol HOOK. HOOKIPA is focused on developing immunotherapies for infectious diseases and cancer.
HB-101 vaccine is currently in Phase 2 clinical development. It has completed a Phase 1 trial and a Phase 2 trial. The Phase 2 trial was conducted in kidney transplant patients with cytomegalovirus infection. The vaccine is still investigational and has not been approved by regulatory authorities.
HB-101 vaccine has been evaluated in two completed clinical trials. The first was a Phase 1 trial (NCT02798692) with 54 healthy volunteers in Belgium. The second was a Phase 2 trial (NCT03629080) with 83 kidney transplant patients across the United States, Denmark, France, Germany, Norway, and the United Kingdom.
HB-101 vaccine is designed to stimulate the immune system to produce a protective response against cytomegalovirus (CMV). It is a vaccine that aims to elicit both antibody and T-cell responses to prevent or control CMV infection. The exact mechanism involves presenting CMV antigens to the immune system to generate immunity.
HB-101 vaccine is a specific vaccine candidate for cytomegalovirus (CMV) infection. It is sometimes referred to as a CMV vaccine in clinical trial titles. However, it is not the same as other CMV vaccines in development. HB-101 is a proprietary vaccine candidate developed by HOOKIPA Pharma.