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The overall aim of this study is to evaluate the safety, immunogenicity and dose sparing effects of H7N9 influenza antigen formulated with 2 different adjuvants .
Following the emergence of avian influenza A/H7N9 influenza virus in humans in China in March 2013, the WHO Essential Regulatory Laboratories prepared candidate vaccine viruses and reagents for further development and several manufacturers have developed various inactivated influenza vaccines with and without adjuvant against A/H7N9 and tested these candidates in trials in healthy adults. The overall aim of this study is to evaluate the safety, immunogenicity and dose sparing effects of H7N9 influenza antigen produced by Butantan Institute in combination with 2 different adjuvants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 15 mcg H7N9 + adjuvant IB160 | Active Comparator | Participants in this arm will receive one dose of the combination (15 mcg H7N9 antigen + adjuvant IB160) at Day 0 and another dose at Day 28. Each dose after combination = 0,5 ml 15 mcg of the monovalent H7N9 antigen per dose |
|
| 7.5 mcg H7N9 + adjuvant IB160 | Active Comparator | Participants in this arm will receive one dose of the combination (7.5 mcg H7N9 antigen + adjuvant IB160) at Day 0 and another dose at Day 28. Each dose after combination = 0,5 ml 7.5 mcg of the monovalent H7N9 antigen per dose |
|
| 3.75 mcg H7N9 + adjuvant IB160 | Active Comparator | Participants in this arm will receive one dose of the combination (3.75 mcg H7N9 antigen + adjuvant IB160) at Day 0 and another dose at Day 28. Each dose after combination = 0,5 ml 3.75 mcg of the monovalent H7N9 antigen per dose |
|
| 15 mcg H7N9 + adjuvant SE | Active Comparator | Participants in this arm will receive one dose of the combination (15 mcg H7N9 antigen + adjuvant SE) at Day 0 and another dose at Day 28. Each dose after combination = 0,5 ml 15 mcg of the monovalent H7N9 antigen per dose |
|
| 7.5 mcg H7N9 + adjuvant SE |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| H7N9 antigen + adjuvant IB160 | Biological | H7N9 monovalent (fragmented and inactivated) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with solicited local Adverse Events over the 7-day period post each study injection. | Solicited local Adverse Events (AE) include erythema, swelling/induration, pain/tenderness, ecchymosis, pruritis. The participant will be given a Participant Diary, a digital thermometer and ruler in which the participant will be asked to record any local and/or systemic reactions. The participant will have been instructed that if he/she experiences an AE requiring medical care, the participant should inform the study staff as soon as possible and seek medical care as appropriate. A visit will be schedule to occur 7 days after each study injection. Study staff will review the Participant Diary and interim history with the participant and inquire about new medical events, which will be recorded in the appropriate Clinical Research Forms. | 7-day period post each study injection (Days 0-6) |
| Number of participants with solicited systemic Adverse Effects over the 7-day period post each study injection. | Solicited systemic Adverse Events (AE) include fever, fatigue/malaise, myalgia, arthralgia, chills, nausea/vomiting, and headache. The participant will be given a Participant Diary, a digital thermometer and ruler in which the participant will be asked to record any local and/or systemic reactions. The participant will have been instructed that if he/she experiences an AE requiring medical care, the participant should inform the study staff as soon as possible and seek medical care as appropriate. A visit will be schedule to occur 7 days after each study injection. Study staff will review the Participant Diary and interim history with the participant and inquire about new medical events, which will be recorded in the appropriate Clinical Research Forms. | 7-day period post each study injection (Days 0-6) |
| Number of participants with unsolicited local and/or systemic Adverse Events over the 7-day period post each study injection. | Unsolicited local and/or systemic Adverse Events include any AE not include in the description of solicited AE, as described in Outcome 1 and 2. The participant will be given a Participant Diary, a digital thermometer and ruler in which the participant will be asked to record any local and/or systemic reactions. The participant will have been instructed that if he/she experiences an AE requiring medical care, the participant should inform the study staff as soon as possible and seek medical care as appropriate. A visit will be schedule to occur 7 days after each study injection. Study staff will review the Participant Diary and interim history with the participant and inquire about new medical events, which will be recorded in the appropriate Clinical Research Forms. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with unsolicited local and/or systemic Adverse Events over the 28-day period post each study injection. | Unsolicited local and/or systemic Adverse Events include any AE not include in the description of solicited AE, as described in Outcome 1 and 2. A visit will be schedule to occur 28 days after each study injection. Study staff will review the Participant Diary and interim history with the participant and inquire about new medical events, which will be recorded in the appropriate Clinical Research Forms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Esper Kallas, PhD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo | Ribeirão Preto | São Paulo | 14015-069 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36256646 | Derived | Vanni T, Thome BC, Sparrow E, Friede M, Fox CB, Beckmann AM, Huynh C, Mondini G, Silveira DH, Viscondi JYK, Braga PE, Silva AD, Salomao MDG, Piorelli RO, Santos JP, Gattas VL, Lucchesi MBB, Oliveira MMM, Koike ME, Kallas EG, Campos LMA, Coelho EB, Siqueira MAM, Garcia CC, Miranda MD, Paiva TM, Timenetsky MDCST, Adami EA, Akamatsu MA, Ho PL, Precioso AR. Dose-sparing effect of two adjuvant formulations with a pandemic influenza A/H7N9 vaccine: A randomized, double-blind, placebo-controlled, phase 1 clinical trial. PLoS One. 2022 Oct 18;17(10):e0274943. doi: 10.1371/journal.pone.0274943. eCollection 2022. |
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| Active Comparator |
Participants in this arm will receive one dose of the combination (7.5 mcg H7N9 antigen + adjuvant SE) at Day 0 and another dose at Day 28. Each dose after combination = 0,5 ml 7.5 mcg of the monovalent H7N9 antigen per dose |
|
| 3.75 mcg H7N9 + adjuvant SE | Active Comparator | Participants in this arm will receive one dose of the combination (3.75 mcg H7N9 antigen + adjuvant SE) at Day 0 and another dose at Day 28. Each dose after combination = 0,5 ml 3.75 mcg of the monovalent H7N9 antigen per dose |
|
| 15 mcg H7N9 without adjuvant | Active Comparator | Participants in this arm will receive one dose of the 15 mcg H7N9 antigen without adjuvant at Day 0 and another dose at Day 28. Each dose = 0,5 ml |
|
| Placebo (PBS) | Placebo Comparator | Participants in this arm will receive one dose of Placebo (PBS) at Day 0 and another dose at Day 28. Each dose = 0,5 ml |
|
| H7N9 antigen + adjuvant SE | Biological | H7N9 monovalent (fragmented and inactivated) |
|
| H7N9 antigen without adjuvant | Biological | H7N9 monovalent (fragmented and inactivated) |
|
| Placebo (PBS) | Biological | Placebo (Phosphate Buffered Saline -PBS) |
|
| 7-day period post each study injection (Days 0-6) |
| 28-day period post each study injection (Days 0-27) |
| Number of participants with Serious Adverse Events over the 222-day period post second study injection. | Serious Adverse Event (SAE) is defined as an adverse event that meets one of the following conditions:
Participants will be contacted by phone on Day 222 after administration of second dose of study product for (a) closure of any ongoing AEs and concomitant medications; and (b) collection of any SAEs and new concomitant medications, if associated with the SAE reported. | 222-day period post the second study injection (Days 0-221) |
| Number of participants that presented seroconversion at day 28, 45 and 56 post first study injection | Seroconvertion is defined as: prevaccination Hemagglutination-inhibition test (HI) antibody titer ≤1:10 and postvaccination HI antibody titer ≥1:40, or prevaccination HI antibody titer ≥1:10 and a postvaccination increase by a factor of four or more). Participants will be invited to return on days 28, 45 and 56 post first study injection, when blood samples will be taken for HI testing. | 56-day period post the first study injection |
| Number of participants that presented seroprotection at day 28, 45 and 56 post first study injection | Seroprotection is defined as postvaccination Hemagglutination-inhibition test (HI) antibody titer ≥ 1:40. Participants will be invited to return on days 28, 45 and 56 post first study injection, when blood samples will be taken for HI testing. | 56-day period post the first study injection |
| Geometric mean of Hemagglutination-inhibition titre at day 28, 45 and 56 post first study injection | Geometric mean of Hemagglutination-inhibition test titre will be calculated for the different groups of participants at day 28, 45 and 56 post first study injection. Participants will be invited to return on days 28, 45 and 56 post first study injection, when blood samples will be taken for HI testing. | 56-day period post the first study injection |
| Centro de Pesquisas Clínicas do Instituto Central do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo | São Paulo | São Paulo | 05403 000 | Brazil |
| Centro de Pesquisa Clínica do Instituto da Criança do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - ICr/HCFMUSP | São Paulo | São Paulo | 05415009 | Brazil |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000277 | Adjuvants, Pharmaceutic |
| ID | Term |
|---|---|
| D010592 | Pharmaceutic Aids |
| D004364 | Pharmaceutical Preparations |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
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