Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of the Bivalent Killed Whole Cell Oral Cholera Vaccine in Eastern Kolkata, West Bengal, India
Brief Summary: The primary purpose of this study is to estimate the efficacy of a two-dose regimen of the oral killed bivalent cholera vaccine when administered to individual residing in a cholera-endemic area in India.


Options:
A: Inclusion Criteria:

* Healthy adult male and non-pregnant female adults aged 18-40 years and healthy children aged 1-17 years

All subjects must satisfy the following criteria at study entry:

* Male or female adult residents aged 18-40 years or children aged 1- 17 years who the investigator believes will comply with the requirements of the protocol (i.e. available for follow-up visits and specimen collection)
* For females of reproductive age, they must not be pregnant (as determined by verbal screening)
* Written informed consent obtained from subjects or their guardians, and written assent for children aged 12-17 years.
* Healthy subjects as determined by: medical history, physical examination, clinical judgement of the investigator.

Exclusion Criteria:

* Ongoing serious chronic disease
* Immunocompromising condition or therapy
* Diarrhea (3 or more loose stools within a 24-hour period) 6 weeks prior to enrollment
* one or two episodes of diarrhea lasting for more than 2 weeks in the past 6 months
* one or two episodes of abdominal pain lasting for more than 2 weeks in the past 6 months
* intake of any anti-diarrhoeal medicine in the past week
* abdominal pain or cramps, loss of appetite, nausea, general ill-feeling or vomiting in the past 24 hours
* acute disease one week prior to enrollment, with or without fever. Temperature \> or = 38 degrees C (oral) or axillary temperature \> or = 37.5 degrees C warrants deferral of the vaccination pending recovery of the subject
* receipt of antibiotics in past 14 days
* receipt of live or killed enteric vaccine in last month
* receipt of killed oral cholear vaccine
B: INCLUSION CRITERIA:

1. Male or female. Females either must be of non-child bearing potential (i.e., surgically sterilized or postmenopausal) or must be using adequate contraception, have a negative pregnancy test, and must agree to continue to use such precautions for 3 months after the last vaccination;
2. Meets DSM-IV-TR criteria for a principal diagnosis of cocaine dependence as confirmed by the MINI;
3. Motivated to discontinue or reduce cocaine use during the period of the study as evidenced both by the judgment of the Investigator or designee and by the subject providing at least 2 urine samples in each of the 2 baseline weeks;
4. In good general health as determined by medical history, general clinical examination, laboratory tests;
5. Has provided written informed consent. Subjects should be cooperative, willing and able to participate and adhere to the Protocol requirements.

EXCLUSION CRITERIA:

1. Subject is cocaine-free (i.e., negative urine results \[BE level\]) during the 2-week screening period;
2. Subject has known immunodeficiency or has a history of autoimmune disease or hypersensitivity to other vaccines. A human immunodeficiency virus (HIV) test must be performed at Screening and reported as negative for HIV-1 and HIV-2;
3. Currently taking medication known to have significant immunosuppressive effects such as systemic glucocorticoids (topical and inhaled formulations are permitted) or oral systemic corticosteroids, within 30 days prior to randomization;
4. Currently taking a dopaminergic, dopamine-blocking, dopamine-modulating, or other central dopamine-altering drug (e.g., antipsychotic drugs); a monoamine oxidase inhibitor (MAOI); or an opiate antagonist;
5. Subject has an unstable medical, neurologic, or psychiatric illness that would interfere with the subject's safety, ability to participate in the study, or the interpretability of data. Subjects who meet the DSM-IV-TR criteria for psychosis, schizophrenia, bipolar disorder or clinically significant suicidal ideation;
6. Subject had dependence on benzodiazepines, barbiturates, opiates or amphetamines according to DSM-IV-TR during the year prior to Screening. Opioid dependence includes methadone or buprenorphine maintenance treatment;
7. Subject requiring medical detox for alcohol dependence;
8. History of sensitivity to aluminium hydroxide gel;
9. History of severe adverse reaction to cholera vaccine;
10. Subject had previous vaccination with TA-CD;
11. Subject received other vaccines, including flu vaccine, within 14 days prior to signing consent;
12. Subject has participated in another clinical trial or received any other investigational compound within 14 days prior to signing consent;
13. Subject has received blood or blood products within the 3 months prior to signing consent;
14. Subject has liver function tests greater than 3 times the upper limit of normal at Screening;
15. Subject has systolic blood pressure higher than 140 mmHg and/or diastolic blood pressure \>90 mmHg;
16. Female subjects with a positive pregnancy test, lactating mothers, women refusing to agree to adequate contraception and pregnancy tests during the study, or women who are planning to become pregnant during the period of the trial. Acceptable contraceptive methods are oral or parenteral hormonal contraceptives, intrauterine device (IUD), or barrier and spermicide, but not abstinence;
17. Male subjects refusing to agree to adequate contraception during the study, or males who are part of a couple planning to become pregnant during the period of the trial;
18. People who are involuntarily detained in a penal institution or people who become involuntarily detained during the study;
19. Any other factor that in the opinion of the Investigator or designee would make the subject unsafe or unsuitable for the study.
C: Inclusion Criteria:

* Healthy non-pregnant adults aged 18-40 years and children aged 1-17 years

Exclusion Criteria:

* Diarrhea during the past week
* Antibiotic and anti-diarrheal medicine use during the past week
* One or more episodes of diarrhea or abdominal pain lasting for 2 weeks during the past 6 months
* Abdominal pain, nausea, vomiting, loss of appetite or generalized ill feeling for the past 24 hours
* Pregnancy
D: Inclusion Criteria:

* All healthy, consenting, non-pregnant (as ascertained by history) residents at least 1 year of age of the study area

Exclusion Criteria:

* individuals who are too weak to get out of bed to receive the vaccine;
* pregnant women (identified through verbal screening); and
* those less than 1 year of age

Answer: D