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Vaccines

Participants receive 3-dose Gardasil-9 vaccine series.

Subunit vaccine against 9 genotypes of human papillomavirus (6, 11, 16, 18, 31, 33, 45, 52, 58)

Human papillomavirus 9-valent vaccine, recombinant

Vice Chancellor for Academic Affairs and Research

Executive Director, Office of Research Services

Jyotsna Fuloria

Jennifer E Cameron, PhD

Michael E Hagensee, MD PhD

Michael E Hagensee, MD, PhD

The primary objective of this study is to determine the magnitude and breadth of the serum antibody response to the nonavalent HPV vaccine (Gardasil-9) in adults with well-controlled HIV infection.

The secondary objective of the study is to observe short term clinical outcomes of prevalent HPV genotype-specific anogenital infections in adults living with HIV who complete the three-dose Gardasil-9 vaccine series.

The clinical hypothesis is that adults with virologically controlled HIV mount a serum antibody response to the nonavalent HPV vaccine that is comparable to HIV negative counterparts. We also postulate that HPV vaccination will provide short-term clinical benefit against HPV infections and disease associated with vaccine genotypes.

BACKGROUND AND SIGNIFICANCE

HPV is the etiological agent for most if not all cervical and anal cancer and for over 50% of head and neck squamous cell carcinomas. HPV infection, pre-cancerous and cancerous lesions are more prevalent in people living with HIV (PLWHIV), including those with HIV infection that is well-controlled with anti-retroviral therapy. HPV vaccines have been developed based on expression of the L1 major capsid protein to make virus-like particles and demonstrate impressive efficacy, with type-specific protection against persistent infection and incident pre-cancer (cervical/anal intraepithelial neoplasia, CIN/AIN) in HIV uninfected populations. These vaccines include quadrivalent Gardasil (4vHPV) and the more recent nonavalent Gardasil (Gardasil-9).

The 4vHPV has been utilized to immunize PLWHIV. In general, excellent seroconversion rates (over 90%) were seen with slightly lower rates seen for HPV-18, and in those with low CD4 cell count, low CD4 cell count nadir or uncontrolled HIV replication. The seroconversion rates appear to be slightly lower than that seen in HIV-negative populations (\>95%). Additionally, titers for HPV-6 and 18 were noted to be lower compared to HIV-negative historical controls in children ages 7-12. This is consistent with observations that vaccination of PLWHIV for influenza, hepatitis A or hepatitis B has resulted in lower than desirable seroconversion rates (50-70%) with higher rates in those on cART and with higher CD4 cell count. To date, only one study has described immunogenicity of Gardasil-9 in adult PLWHIV. Investigators have reported seroconversion to all 9 HPV types in all 100 immune-intact/virally suppressed PLWHIV who received Gardasil-9, and higher antibody GMTs in those with pre-existing seroreactivity. This cohort study conducted in Belgium included predominantly Caucasian (68%) males (85%) with a mean age of 38 years at enrollment. There is a paucity of literature exploring the immunogenicity of Gardasil-9 in diverse demographic populations of adults living with HIV.

Efficacy studies using 4vHPV in HIV-positive adults have provided mixed results at best. One study in HIV-positive men and women who had significant prior HPV exposure showed no efficacy of HPV vaccination in preventing future AIN2/3 development. This may be related to the inclusion of men and women with AIN2/3 at baseline (30% and 50%, respectively) and the older age (average, 47) of this cohort. In another study of females aged 9-65 (average, 39) with 2 years of follow up, 4vHPV showed modest efficacy with rates of 1.0/100 patient-years for a composite endpoint of the development of warts or persistent infection with the vaccine types. This compares to rates of 0.1/100 patient-years for HIV-uninfected women and 1.5 for HIV-negative unvaccinated women. The reason for this modest efficacy is not clear but may be due to deficiencies in cellular immunity and/or the age of the cohorts. In addition, many of these HIV infected individuals have been previously exposed to some of the vaccine types and they often have concurrent infections with other oncogenic HPV types. These excessive HPV exposures may promote CIN/AIN and confound efficacy endpoints. Importantly, HIV positive women with CIN3+ have a nearly 4-fold higher prevalence of non-traditional oncogenic HPV types compared to HIV negative women with CIN3+. This finding suggests that the modest efficacy of 4vHPV in HIV positive women may be improved substantially by use of Gardasil-9. To date, no studies have reported efficacy of Gardasil-9 for prevention of HPV infections, CIN or AIN in adult PLWHIV.

There is clearly an unmet need to evaluate the immunogenicity and immune protection generated by Gardasil-9 vaccination in diverse populations of PLWHIV, who remain at increased risk of HPV infection and related pathology despite adequate management of their HIV. We hypothesize that people with well-controlled HIV will seroconvert following Gardasil-9 vaccination and will develop high titer antibodies to all 9 HPV types. In addition, we postulate that the well-controlled HIV-positive individual will also show short-term efficacy with fewer incident HPV infections and reduced incidence of CIN/AIN attributed to HPV types in the vaccine. This efficacy will primarily be seen in those who are seronegative and HPV DNA negative for a given type at baseline. It is predicted that those who are seropositive but HPV DNA negative for a given vaccine type will demonstrate higher titers of response after vaccination. Efficacy in this subset (seropositive, DNA negative) as well as the other subsets has not been studied in detail. The goal of these proposed studies is to show immunogenicity and short-term efficacy of Gardasil-9 in a well-controlled HIV-positive population.

STUDY DESIGN AND PROCEDURES

This study is a single-center, prospective, intervention trial evaluating the immunogenicity of Gardasil-9 in adult men and women living with adequately managed HIV infection. The study will include both men and women and will reflect the gender, race, ethnicity, sexual orientation and socioeconomic status of the patient population seeking care at University Medical Center.

After informed consent is secured, all enrolled participants will receive the 3-dose Gardasil-9 vaccine per product label at 0, 1 and 6 months. Subjects will be observed for at least 30 minutes after the vaccination is given. Participants consenting to the study will complete a sociodemographic survey at the enrollment visit. At 0, 7, 12, and 18-month visits, participants will complete a social history survey and whole venous blood, saliva, and anal swabs will be collected. A cervical/vaginal swab will also be collected from female participants. Whole blood will be processed to obtain serum, which will be aliquoted and stored at -80C. Serum samples will be tested for HPV antibodies by the competitive Luminex immunoassay (cLIA, Merck) to determine seroconversion rates and antibody titers. Genomic DNA isolates from saliva and swabs will be tested for HPV genotype-specific infection by high-throughput sequencing (HPV MY-Seq). Results of clinical laboratory tests pertinent to the study will be captured from the participant's electronic medical record. For patients who undergo cervical colposcopy or anoscopy with biopsy for clinical care, residual biopsy specimens will be obtained from UMC Pathology for HPV DNA genotype testing.

The immunological response of study participants will be compared to previously published historical (HIV negative adult) controls. Additionally, clinical outcomes of prevalent and incident HPV genotype-specific infection and anogenital dysplasia will be evaluated, comparing those participants who seroconvert/generate high titer antibodies to those who do not seroconvert/generate low titer antibodies, and comparing high-risk HPV genotypes included in the vaccine to high-risk HPV genotypes that are not included in the vaccine.

PLANNED ANALYSIS

The primary outcome of the study is seroconversion to the 9 HPV genotypes in the Gardasil-9 vaccine. This outcome will be analyzed as a binary variable (seropositive/seronegative) and as a continuous numerical value (antibody titers). Secondary outcomes of the study will evaluate the impact of vaccination on HPV infection and disease. Variables of interest include prevalent HPV infection, incident HPV infection, prevalent HPV-associated dysplasia, and incident dysplasia. Clinical outcome variables will also be interpolated from the data, including clearance and/or persistence of HPV infection and clearance, persistence or progression of HPV-associated disease. All disease will be evaluated on a per-site (mucosal tissue) basis and definitions for HPV related variables will depend on genotype-specificity. All variables will be collected at each 6-month timepoint. Time-to-event (e.g. viral clearance, progression of lesion) will also be extracted from the prospective data to evaluate clinical impacts of vaccination. Data will be stratified by demographic and social history variables to identify predictors of seroconversion and clinical outcomes and control for confounding factors.

Statistical Methods: Categorical covariates will be described by reporting counts and percentages, while continuous covariates will be reported using means and standard deviations. Categorical covariate distributions will be compared between seropositive/negative groups using a Fisher exact test, and continuous covariates will be compared using Wilcoxon rank sum tests. To test the primary hypothesis - that seropositivity rates do not differ from published rates of 95% in HIV-negative populations - a one-sided one-sample test of proportions will be used.

In order to determine what demographic factors influence variables in this population after potential confounder adjustment, several regression analyses will be used. For binary variables, logistic regression will be used, while for continuous variables typical linear regression is used. For time to event variables, Cox regression will be used, and for variables that are proportions, Beta regression will be used. When using repeated measurements, independence will be maintained by controlling for subject ID as a random or fixed effect. If necessary, Bayesian methods will be used.

Power/Sample Size: Assuming a seroconversion rate of 95% in HIV-negative patients, 150 enrolled patients would give power of about 99% to detect a seroconversion rate of 80%. The design also has a power of 80% if the true seroconversion rate in Gardasil patients is 89%. The design will not be well powered to detect decreases \<6% in seroconversion rates from the published literature.

Single-arm trial of serological response to Gardasil-9 HPV vaccine in immunocompetent adults (age 18-45) with HIV infection. All study participants will receive Gardasil-9 3-dose series.

Immunogenicity of Gardasil-9 HPV Vaccine in People Living With HIV

Prospective Observational Immunogenicity Trial of Gardasil-9 HPV Vaccine in People Living With Adequately Managed HIV

serum antibodies against human papillomavirus genotypes 6,11,16,18,31,33,45,52, and 58

time-to-clearance of prevalent HPV infection of the oral cavity, vaginal tract and/or anal canal

acquisition of genotype-specific HPV infection following Gardasil-9 immunization at mucosal sites (oral cavity, genital tract, anal canal)

Merck Sharp & Dohme LLC

Louisiana State University Health Sciences Center in New Orleans

Assistant Professor

Respiratory Tract (Lung and Bronchial) Diseases

COVID-19

vaccined salaried staff group (Distinction between

* Employees vaccinated with two doses of vaccine (2 Pfizer doses or 2 Astra doses or 1 Pfizer dose + 1 Astra dose) and never infected with SARS-CoV-2
* And employees vaccinated with one dose of Pfizer or Astra vaccine and previously infected with SARS-CoV-2

non vaccined salaried staff group wtih positive SARS-CoV-2

27 mL blood sample to study the humoral and the cellular immune response

serology and ELISPOT test

7 mL blood sample to study the humoral response

serology

Special populations are people with a risk to dévelop severe forms of a disease. The immunogenicity and efficacy of vaccines in this population may be different compared of the general population.

For Covid-19, special populations are people with chronic diseases (obesity, diabetes, cancer, etc.) and / or immunocompromised and / or elderly. It is therefore important that the safety of new vaccines as well as their efficacy be evaluated.

Thus, in cancer, most immunosuppressions and immunosuppressive treatments (in particular chemotherapy or certain targeted therapies) risk negatively impacting the effectiveness of the anti-SARS-COV-2 vaccine both for the humoral immune responses (antibodies ) and cellular (T lymphocytes). These patients may develop an insufficient post-vaccination immunity. However, it seems that immunosenescence (ie the aging of the immune system) has little impact on the effectiveness of mRNA vaccines and viral vector vaccines.

The Canserovax study evaluates the impact of anticancer treatments on the quality of the humoral (development of antibodies) and cellular (development of a specific T response) immune response to SARS-CoV-2 in patients treated for cancer after vaccination. It is carried out in patients undergoing treatment and in subjects not suffering from cancer, and not treated for this pathology (vaccinated salaried staff of a french cancer center). The aim is to qualitatively and quantitatively compare the post-vaccination immune responses in these 2 populations.

The main objective of this study is to describe after anti-SARS-CoV-2 vaccination the humoral immune response against the virus (assay of anti-SARS-CoV-2 antibodies to detect the presence and intensity of humoral immune responses) and the cellular response against the virus (specific T response).

Several cohorts are studied:

* Cohort 1 of vaccinated salaried staff (First group : Employees vaccinated with two doses of vaccine (2 Pfizer doses or 2 Astra doses or 1 Pfizer dose + 1 Astra dose) and never infected with SARS-CoV-2) and second group (Employees vaccinated with one dose of Pfizer or Astra vaccine and previously infected with SARS-CoV-2)
* Cohort 2 of unvaccinated salaried staff (controls)
* Cohort 3 of vaccinated cancer patients (metastatic colorectal, metastatic pancreas and metastatic breast cancer)

Mechanisms of Anti COVID-19 Humoral and Cellular Immune Response After Vaccination in a Sample of Patients and Salaried Staff From a French Anti-cancer Center

Study of Mechanisms of Anti COVID-19 Humoral and Cellular Immune Response Between 1 and 3 Months After Vaccination in a Sample of Patients and Salaried Staff From a French Anti-cancer Center

rate of specific SARC-Cov-2 IgM and IgG and Human IFN-γ SARS-CoV-2 ELISpot

Centre Georges Francois Leclerc

Influenza, Human

Antibodies

Immunoglobulins

Immunologic Factors

This study is designed to investigate the antibodies titers before and after the novel H1N1 influenza vaccination in pediatric haemato-oncology patients.

Serology study before and after Influenza A (2009) monovalent vaccine, inactivated

Influenza A (H1N1) 2009 monovalent vaccine, inactivated

Luan-Yin Chang, MD

The patients of pediatric haemato-oncology have a higher risk for novel H1N1 influenza infection than general population, and they are strongly recommended to receive novel H1N1 vaccination. However, there is no previous data to answer how the efficacy and effectiveness of novel H1N1 vaccination is in patients of pediatric haemato-oncology. This study is designed to investigate the antibodies titers before and after the novel H1N1 influenza vaccination in these patients. Titer of H1N1 influenza virus antibodies will be determined by hemagglutinin inhibition assay (HAI). A HAI titer with a 4-fold rise or greater is defined as seroconversion. Study subjects with seroconversion are regarded as responsiveness to the vaccination. Meanwhile, if the patient presents influenza-like symptoms, we will perform throat swab or nasal swab for influenza rapid test, viral isolation, and novel H1N1 influenza PCR to confirm the diagnosis. After the study, we will be able to know whether or not current novel H1N1 influenza vaccination schedule is adequate and efficient for pediatric haemato-oncology patients.

The emergence of novel H1N1 influenza in 2009 has a great impact to the societies in Taiwan and worldwide. The patients of pediatric haemato-oncology have a higher risk for novel H1N1 influenza infection than general population, and they are strongly recommended to receive novel H1N1 vaccination. However, there is no previous data to answer how the efficacy and effectiveness of novel H1N1 vaccination is in patients of pediatric haemato-oncology. This study is designed to investigate the antibodies titers before and after the novel H1N1 influenza vaccination in these patients. Thus two blood samples will be drawn. The first sample will be collected before the vaccination and the second one will be collected three weeks after the vaccination (If the patient is younger than 9 years old, the third sample will be collected three weeks after the booster vaccination). Titer of H1N1 influenza virus antibodies will be determined by hemagglutinin inhibition assay (HAI). A HAI titer with a 4-fold rise or greater is defined as seroconversion. Study subjects with seroconversion are regarded as responsiveness to the vaccination. We will analyze seroconversion rate as well. Meanwhile, if the patient presents influenza-like symptoms, we will perform throat swab or nasal swab for influenza rapid test, viral isolation, and novel H1N1 influenza PCR to confirm the diagnosis. After the study, we will be able to know whether or not current novel H1N1 influenza vaccination schedule is adequate and efficient for pediatric haemato-oncology patients.

Serum for serology of H1N1 antibody Nasopharyngeal or oropharyngeal swab for Novel H1N1 PCR

Antibody Titer Analysis After H1N1 Vaccination in Pediatric Haemato-oncology Patients

Antibody Titer Analysis Afer Monovalent Vaccination in Pediatric Haemato-oncology Patients

National Taiwan University Hospital

Serological diagnosis of COVID-19 in patients with cancer from a sample of cancer patients, at 3 and 6 months after implementation of confinement in France

Serology

The public health council (Haut Conseil de Santé Publique) published a statement on 14 March 2020 relating to the management of patients with severe forms of COVID-19, stipulating specific recommendations for patients with cancer.

The statement notes that patients with cancer at much higher risk (four to five times higher) of several respiratory complications, which develop very rapidly, especially if they had recently undergone surgery or chemotherapy in the previous few weeks, and that this risk could be life-threatening, on top of the cancer-related risk. In addition, the statement noted that:

* COVID-19 appears to be more frequent in patients with cancer than among the general population (1% vs 0.29%)
* Among those infected, the risk of severe respiratory complications requiring admission to the intensive care unit (ICU) is higher in patients with cancer than among those without (39% vs 8%, P=0.0003).
* A history of chemotherapy or surgery in the previous months is an important prognostic factor for the development of severe respiratory complications (odds ratio (OR) = 5.34, P= 0.0026).
* Deterioration of respiratory function occurs more quickly in patients with cancer (13 vs 43 days, hazard ratio (HR) 3.56, 95% confidence interval (CI) \[1.65-7.69\]).

In addition, COVID-19 may lead to a change in the diagnostic and therapeutic management of patients with cancer, with potential consequences such as use of oral treatments at home, discontinuation of anticancer therapy depending on the context, or prioritization of management according to curative/palliative treatment type, age, and line of therapy.

International studies previously reported the psychological repercussions of major epidemics on the emotional state. The impact of COVID-19 on patients with cancer therefore warrants evaluation, among cancer patients in the French West Indies, in the current situation of nationwide lockdown.

Realization of the COVID -19 serological profile of cancer patients

Prioritising Prevention of COVID-19 in Persons With Cancer in the French West Indies

Prioritising Prevention of COVID-19 in Persons With Cancer in the French West Indies: Monitoring Psychological Impact to Optimize Healthcare Delivery Strategies in Unique Public Health Circumstances

Evaluation of presence of psychiatric disorders by questionnaire after the initiation of population-level confinement due to the COVID-19 epidemic

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Immunogenicity of Gardasil-9 HPV Vaccine in People Living With HIV	NCT05266898	Papillomavirus ... Human Immunodef... Papillomavirus ... Serology Cervical Intrae... Anal Intraepith... Oral Cavity Inf...	Human papilloma...	18 Years - 45 Years	Louisiana State University Health Sciences Center in New Orleans
Mechanisms of Anti COVID-19 Humoral and Cellular Immune Response After Vaccination in a Sample of Patients and Salaried Staff From a French Anti-cancer Center	NCT04935528	Cancer	serology and EL... serology	18 Years -	Centre Georges Francois Leclerc
Antibody Titer Analysis After H1N1 Vaccination in Pediatric Haemato-oncology Patients	NCT01046227	Serology Analys... Novel H1N1 Infl... Pediatric Haema...	Influenza A (H1...	6 Months - 18 Years	National Taiwan University Hospital
Prioritising Prevention of COVID-19 in Persons With Cancer in the French West Indies	NCT04768153	Cancer	Serology	18 Years -	University Hospital Center of Martinique
Mechanisms of Anti COVID-19 Humoral and Cellular Immune Response After Vaccination in a Sample of Patients and Salaried Staff From a French Anti-cancer Center	NCT04935528	Cancer	serology and EL... serology	18 Years -	Centre Georges Francois Leclerc

Spots Global Cancer Trial Database for serology

Every month we try and update this database with for serology cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for serology

Every month we try and update this database with for serology cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for serology cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.